General Dosing Considerations for Epilepsy and Bipolar Disorder Patients The risk of nonserious rash is increased when the recommended initial dose and/or the rate of dose escalation of lamotrigine tablets is exceeded. There are suggestions, yet to be proven, that the risk of severe, potentially life-threatening rash may be increased by (1) coadministration of lamotrigine tablets with valproate, (2) exceeding the recommended initial dose of lamotrigine tablets, or (3) exceeding the recommended dose escalation for lamotrigine tablets. However, cases have been reported in the absence of these factors (see BOX WARNING). Therefore, it is important that the dosing recommendations be followed closely. It is recommended that lamotrigine not be restarted in patients who discontinued due to rash associated with prior treatment with lamotrigine, unless the potential benefits clearly outweigh the risks. If the decision is made to restart a patient who has discontinued lamotrigine, the need to restart with the initial dosing recommendations should be assessed. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. If a patient has discontinued lamotrigine for a period of more than 5 half-lives, it is recommended that initial dosing recommendations and guidelines be followed. Special Populations Women and oral contraceptives Adjustments to the maintenance dose of lamotrigine (1) Taking Estrogen-Containing Oral Contraceptives: For women not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, the maintenance dose of lamotrigine will in most cases need to be increased, by as much as 2 fold over the recommended target maintenance dose, in order to maintain a consistent Will biosimilars emerge lamotrigine plasma level (see PRECAUTIONS, Drug Interactions). (2) Starting Estrogen-Containing Oral Contraceptives: In women taking a stable dose of lamotrigine and not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, the maintenance dose will in most cases need to be increased by as much as 2 fold, in order to maintain a consistent lamotrigine plasma level. The dose increases should begin at the same time that the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to to revive generics rush? 100 mg/day every week. Dose increases should not exceed the recommended rate unless lamotrigine plasma levels or clinical response support larger increases (see Table 11, column 2). Gradual transient increases in lamotrigine plasma levels may BY ALARIC DEARMENT occur during the week of inactive hormonal preparation (“pill-free” week), and these increases will be greater if dose increases are made in the days before or during the week of inactive hormonal preparation. Increased lamotrigine plasma levels could Value of products losing patent protection result in additional adverse events, such as dizziness, ataxia, and diplopia (see PRECAUTIONS, Drug Interactions). If adverse events attributable to lamotrigine The 1840s had the Cali- $21 consistently occur during the “pill-free” week, dose adjustments to the overall $20 maintenance dose may be necessary. Dose adjustments limited to the “pill-free” week $19 $19 are not recommended. For women taking lamotrigine in addition to carbamazepine, fornia Gold Rush. The 1990s phenytoin, phenobarbital, primidone, or rifampin, no adjustment should be necessary to the dose of lamotrigine. (3) Stopping Estrogen-Containing Oral Contraceptives: had the tech boom. Years For women not taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin, the maintenance dose of lamotrigine will in most cases need to be from now, historians might decreased by as much as 50%, in order to maintain a consistent lamotrigine plasma $15 level. The decrease in dose of lamotrigine should not exceed 25% of the total daily dose per week over a 2 week period, unless clinical response or lamotrigine plasma label the early 2000s the $13 levels indicate otherwise (see PRECAUTIONS, Drug Interactions). For women taking lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or generic drugs rush. rifampin, no adjustment to the dose of lamotrigine should be necessary. $11 Patients With Hepatic Impairment But whatever they call it, Experience in patients with hepatic impairment is limited. Based on a clinical $9 pharmacology study in 24 patients with mild, moderate, and severe liver dysfunction (see CLINICAL PHARMACOLOGY), the following general recommendations can be the big growth years may be made. No dosage adjustment is needed in patients with mild liver impairment. Initial, $7 escalation, and maintenance doses should generally be reduced by approximately behind the $6 25% in patients with moderate and severe liver impairment without ascites and 50% $5 in patients with severe liver impairment with ascites. Escalation and maintenance industry. In fact, some be- doses may be adjusted according to clinical response. Patients over 12 years of age $3 $3 Recommended dosing guidelines are summarized in Table 11. lieve that over the course of Table 11. Escalation Regimen for Lamotrigine in Patients Over 12 Years of Age With Epilepsy the next five years or so, the For Patients Taking For Patients Taking AEDs Other Than Carbamazepine, boom even could go bust, as Carbamazepine, Phenytoin, 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 For Patients Taking Phenytoin, Phenobarbital, Valproate a shortage of big block- Phenobarbital, Primidone* Source: IMS Health Primidone, or and not Taking buster drug launches today Valproate* Valproate Dollars in billions 25 mg every other Weeks 1 and 2 25 mg every day 50 mg/day day means a dropoff in the 100 mg/day Weeks 3 and 4 25 mg every day 50 mg/day (in 2 divided number of new generic lan and Dr. Reddy’s Phar- Pharmaceutical Association doses) Weeks 5 Increase by 25 to Increase by Increase by introductions tomorrow— maceutical have become in- spokesman Charlie Mayr said. onwards to 50 mg/day every 50 mg/day every 100 mg/day every maintenance 1 to 2 weeks 1 to 2 weeks 1 to 2 weeks pointing to even stiffer com- creasingly prominent as “There are a large number of 100 to 400 mg/day 225 to 375 300 to 500 Usual (1 or 2 divided doses) mg/day mg/day Maintenance 100 to 200 mg/day (in 2 divided (in 2 divided petition for a generic drug they swallow up formerly branded products coming off Dose with valproate alone doses) doses) market that grows steadily patented drug compounds patent in the next five years.” * Rifampin and estrogen-containing oral contraceptives have also been shown to increase the apparent clearance of lamotrigine (see PRECAUTIONS, Drug Interactions). Discontinuation Strategy in Bipolar Disorder more commoditized. and market their own, chea- By the end of this year, for As with other AEDs, lamotrigine tablets should not be abruptly discontinued. In the controlled clinical trials, there was no increase in the incidence, type, or severity of Between 2008 and 2013, per equivalents. example, GlaxoSmithKline adverse experiences following abrupt termination of lamotrigine. In clinical trials in patients with bipolar disorder, 2 patients experienced seizures shortly after abrupt withdrawal of lamotrigine. However, there were confounding factors that may have 183 branded drugs will lose “As long as brand compa- will have lost its patents for contributed to the occurrence of seizures in these bipolar patients. Discontinuation of lamotrigine tablets should involve a step-wise reduction of dose over at least 2 weeks their patent protections, nies continue to innovate, the anxiety drug Paxil CR (approximately 50% per week) unless safety concerns require a more rapid withdrawal. Manufactured In Israel By: making them fair game for there will be a strong and (paroxetine hydrochloride), TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel generic drug manufactur- vibrant generic pharmaceuti- antidepressant Wellbutrin XL Manufactured For: USA ers. Already, such drug cal industry ready, willing and (bupropion hydrochloride), Sellersville, PA 18960

Rev. B 11/2007 makers as Barr Labs, able to provide affordable anti-seizure and bipolar disor- Ranbaxy Laboratories, My- generic medicines,” Generic CONTINUED ON PAGE 5 Working the generics numbers: A firmer bottom line as sales decline BY JIM FREDERICK equivalents, drug retailers will see increase in pharmacy margins due a significant drop in topline to the growth in generic drug For the bean counters at the sales,” said Citi Investment Re- sales,” the company reported. But it nation’s drug, supermarket and dis- search analyst Deborah Weinswig. can be a complicated profit and count store chains, generic drugs can Indeed, Weinswig added, the sales calculus. be a double-edged sword. recent introduction of new gener- “In the case of some blockbuster On the one hand, the loss of patent ics has pulled down comp-store generic drugs, it’s difficult to grow protection on a big-selling branded sales for the retail pharmacy profit dollars after their first few drug means multisource drug com- industry by 460 basis points, or months of availability,” said petition, which, in turn, can mean nearly half a percent. Walgreens president Greg Wasson. significantly lower topline sales. But However, she added, “Generics “Pharmacy gross profit margins on the flip side for generic switches have superior gross margins versus some drugs can increase on a percent- often is dramatically higher gross branded drugs [50 percent versus 15 age basis even while the gross profit margins, at least for an initial period percent, respectively]. As such, in dollars they produce fall.” of availability. the first full year [of their introduc- Meredith Adler, retail analyst for Generics clearly can bolster prof- tion], generics actually are a net pos- Lehman Brothers, noted that the itability both for pharmacy retailers itive to retailer profits.” continuing shift of big-selling The use of generic drugs will result in lower and pharmacy benefit managers A case in point is Walgreens. In branded drugs to generics continues topline sales, but higher gross margins, albeit on because they offer a higher gross mar- the company’s fiscal 2008 third to impact Walgreens’ sales. “August lower sales. gin, albeit on lower sales. quarter, a slide in front-end margins comps of 3 percent…were below generics, Zyrtec going OTC and cal- “Since prices of generics are sig- due to expanded promotional acti- our forecast of 4 percent,” she wrote endar shifts, the adjusted Rx comp nificantly less than their branded vity was “partially offset by an last month. “After adjusting for new CONTINUED ON PAGE 4

Drug Store News www.drugstorenews.com September 2008 • 1 Both candidates opening doors Q&A Breaking down for generic drug business the deal Chuck Caprariello, BY JIM FREDERICK Ranbaxy Laboratories WASHINGTON — For the generic A major stake of Ranbaxy Laboratories, ’s largest drug industry, the 2008 presi- pharmaceutical company, with operations in 49 coun- dential election could bring tries and global sales of $1.6 billion, was acquired by good news no matter which Japanese branded drug maker . Drug candidate reaches the White Store News talked with Chuck Caprariello, Ranbaxy’s House next January. vice president of corporate communications and gov- For all their differences, ernment affairs, about what the deal means. Democratic Sen. Barack Obama of Illinois and Republican Sen. Drug Store News: What does the acquisition John McCain of Arizona do mean for the two companies? share some common ground on Both presidential candidates, Sens. John McCain and Barack Obama, have mentioned generic drugs in the viability and usefulness of their campaign platforms, but Obama has made the most promises to promote the industry. Chuck Caprariello: It’s obviously a combination of two me-too as safe and “We all value the medical cures organizations—a generic and an innovative brand cost-effective alternatives to “Under either party, and innovations that the pharma- company—that will rely on the talent of both to achieve branded drugs. And that could ceutical industry has developed business objectives through synergies in research and be a positive for generic drug the drug stores should over the years, but it’s become development, sales and marketing and manufacturing makers and retail pharmacies, clear that some of these compa- efficiencies. said Citi Investment Research benefit with the con- nies are dramatically overcharg- As our chief executive officer Malvinder M. Singh, analyst Deborah Weinswig ear- ing Americans for what they said: ‘It places Ranbaxy in a higher growth trajectory, lier this year. tinued movement to offer,” Obama asserted. going forward.’ Daiichi Sankyo and Ranbaxy are best “Under either party, the drug “We don't have to stand for that positioned to gain from the complementary strengths stores should benefit with the generics offsetting anymore,” he added. of both partners to capitalize on the various growth continued movement to generics McCain’s support for generics opportunities across the pharmaceutical value chain. offsetting brand name and Medi- brand name and as a cost-saving tool for health caid pricing pressures,” Wein- care also appears genuine: He DrSN: What does it mean for pharmacy? swig said. “Additionally … the Medicaid pricing was a co-sponsor, along with next Congress will probably pass Democratic Sen. Charles Caprariello: From a sales and marketing point of view, a law that allows for expedited pressures. Schumer of New York, of the more products are anticipated to be evolving from the approval of generic versions of ” Greater Access to Affordable combined company, with each one working separately in biotech drugs.” Pharmaceuticals Act of 2001. The the brand and generic sectors of the pharmaceutical mar- “This should benefit the Deborah Weinswig, bill’s aim: to cut down on road- ket, which will be of benefit to pharmacist, prescribers margins on specialty pharma- Citi Investment Research blocks to generic drug and, most important, to patients. By combining Ranbaxy ceuticals, which are a growth approvals and ease their way to plus the Daiichi Sankyo sales turnover, it will create driver for the drug stores, and too drug industry has been the market with an accelerated date the 15th-largest global pharmaceutical company. accelerate the increased mix of Democratic senator from Illinois. for approval of generic drug generics,” Weinswig contin- “Obama will work to increase the applications. Among its other DrSN: What are the greatest strengths of the deal? ued. She added that drug use of generic drugs in Medicare, provisions, the bill granted retailers “may benefit slightly Medicaid and FEHBP and prohib- branded drug companies only Caprariello: We have two companies operating that are more under McCain, as he it big-name drug companies from one automatic 30-month stay on working synergistically, which together will have a sig- highlights retail in-store clinics keeping generics out of markets,” generic competition for filing a nificant impact on healthcare systems worldwide. as a health-cost solution.” noted a position statement from patent- infringement suit. It also What’s more, said Paul the candidate. impeded the practice of author- DrSN: What are some challenges? Heldman, a director and senior Taking an assertive populist ized generics, by invalidating a health policy analyst at Citi- stance, Obama long has made 180-day period of exclusivity for Caprariello: Taking two organizations with slightly differ- group, “Both Sens. McCain and it clear that he’d work to even a generic drug maker that ent orientations—the innovator mindset and the Obama want a greater … the playing field between makes a deal with a branded generic orientation—and combining them to derive the investment in health informa- branded and generic drug firm to keep a generic alterna- anticipated benefits. For the acquisition to occur in a tion technology.” The result, he makers. Equally clear has been tive off the market. timely fashion will be another challenge. said, could be “a positive for his suspicion of the lobbying The bill drew the ire of the pharmacy to the extent that, clout and economic power branded drug industry but DrSN: What’s next? through initiatives like e-pre- held by the branded industry. praise from consumer groups. Caprariello: Daiichi Sankyo has acquired a 30-plus per- scribing, there’s greater generic “We will break the strangle- McCain’s campaign platform cent stake in Ranbaxy and will acquire an additional 20 drug substitution, a higher- hold that a few big drug and calls for “greater competition percent to have a majority position. The need to create margin business for them and insurance companies have on to our drug markets through a revised board of directors representing both compa- for the PBM.” the healthcare market,” he safe re-importation of drugs nies to effectively manage the Ranbaxy business will The most assertive election- vowed in a speech in Iowa and faster introduction of be a priority. year advocate on behalf of the me- early in his campaign. generic drugs.” 2 • September 2008 www.drugstorenews.com Drug Store News Wal-Mart leads the way into REPORTERSNotebook Supplier News — Teva has released generics price-cut skirmish the first generic nicardipine hydrochlo- ride injection, the generic drug BY ALARIC DEARMENT maker announced this month. The injection is equivalent to In September 2006, Wal-Mart dropped a bomb- EKR Therapeutics’ blood-pres- shell: The retailer announced that it would start sure drug Cardene and is selling 30-day supplies of a host of generic drugs available in doses of 2.5 for $4. It wasn’t the innovator in this case—Kmart mg/mL to 25 mg/10mL. Car- began selling 90-day supplies of generic drugs for dene had sales of $40.5 million $15 in May of that year—but Wal-Mart’s decision in second quarter 2007, ac- has created a brutally competitive environment. cording to Forbes. Teva’s generic nicardipine In May 2008, Wal-Mart expanded the program to “Our customers look to us injection include 350 drugs and began offering 90-day sup- for a continuous supply of new plies for $10, prompting Kmart to lower its price health systems generics,” Teva marketing and expand its list of medications offered to more director Jennifer Guzman said. “Teva’s than 500. Not surprisingly, several other retailers commitment to new product develop- have followed suit. ment assures important new products like The same day that Wal-Mart announced the expan- nicardipine hydrochloride injections are sion of its program, Target announced that it also available on a timely basis.” would expand a similar program for the same price. The list of retailers offering the programs now includes The Food and Drug Administration most big-box stores, a growing number of supermar- approved Dr. Reddy’s trandolapril tablets kets and even a few retail pharmacies that have fol- in 1 mg, 2 mg and 4 mg strengths. lowed the lead of Kmart and Wal-Mart this year. The tablets are a generic version of Abbott’s Mavik, a hypertension drug. Ma- April vik had sales of $49 million in 2006, Kroger began offering 30-day supplies of drugs Wal-Mart created a highly competitive environment when it began selling according to IMS Health data. for $4 at its stores. It soon extended the program 30-day supplies of selected generics for $4 in September 2006. A number of other companies already to two of its banners on the West Coast, big-box sell generic versions of the drug, includ- chain Fred Meyer and supermarket chain QFC. $10 and 30-day supplies for $4 at its 205 stores in ing Mylan, Teva, Cipla and Cobalt. Pennsylvania, Maryland, West Virginia and Ohio. Unichem Laboratories has received The list of retailers offering the June approval from the FDA for hydrochloroth- Safeway started offering 30-day supplies of iazide tablets. reduced-cost generics programs generic drugs for $4 at its stores in New Jersey, The tablets, available in 25 mg and 50 Delaware, Virginia, Maryland and the Chicago mg strengths, are used to treat edema, or area, following a pilot program at its Dallas and fluid retention resulting from congestive now includes most big-box stores, Houston stores in March. heart failure, as well as kidney disorders Giant Food started offering 90-day supplies of and cirrhosis of the liver. a growing number of supermar- 350 generic drugs for $9.99 at its stores in Virginia, The new drug is a generic version of Maryland, Delaware and the District of Columbia. GlaxoSmithKline’s Dyazide. The FDA kets and even a few retail phar- also approved Unichem’s formulations July plant in Ghaziabad, India. macies that have followed the lead Dierbergs Markets started offering 30-day sup- plies of drugs for $4 and 90-day supplies for $10. The FDA has granted final approval to of Kmart and Wal-Mart this year. Hy-Vee started offering 90-day supplies of Aurobindo Pharma to market a generic drugs for $10 at its supermarket pharmacies and version of Merck’s Fosamax tablets. drug stores. The tablets, whose active ingredient is alendronate sodium, will be available in May August strengths of 10 mg, 35 mg and 70 mg for Belgian supermarket operator Delhaize Group Walgreens started selling 90-day supplies of the treatment of osteoporosis. announced that it would start selling 30-day more than 400 generic drugs for $12 as part of its The FDA has also given approval to supplies of more than 400 generic drugs for $4 Prescription Savings Club, in addition to savings Dr. Reddy’s to market a version of and 90-day supplies for $10.99. The drugs on more than 5,000 other generic and brand- the drug. include the antipsychotic drug haloperidol, the name drugs, though it extended the offer only to Fosamax and Fosamax Plus D (alen- thyroid hormone levothyroxine and the respira- members of the club. dronate sodium/cholecalciferol) had tory drug albuterol. Sav-Mor Drug Stores began offering 30-day sup- worldwide sales of $411 million, accord- Supermarket chain Giant Eagle began offering plies of more than 300 generic drugs for $4 and 90- ing to Merck financial data. more than 400 generic drugs in 90-day supplies for day supplies for $11.99 at its stores. Drug Store News www.drugstorenews.com September 2008 • 3 In general, pharmacy ben- ness, are also pushing for push generic substitution ently higher margins offered Bottom line efit managers, which control higher profit margins as rates for their member by generics, and the spread CONTINUED FROM PAGE 1 the dominant share of the more blockbuster branded patients. In doing so, PBMs between generic costs and of 5.8 percent was inline nation’s prescription busi- drugs go off patent and they are exploiting both the inher- reimbursement rates. with the comparable July result of 5.6 percent.” Adler said the introduc- tion of new generics put a 2.4 percent drag on Walgreens’ same-store sales in August. In addition, she reported, “The company cited several factors that may be impact- ing sales, including the aggressive rollout of the $4 generic drug programs at nearby supermarkets.” The impact that multi- source drugs has on sales and profits plays through- out the retail pharmacy industry. In CVS’ 2007 annual report to sharehold- ers, chairman, president and chief executive Tom Ryan spoke to that impact. “Gross margins increased in both our retail and PBM busi- nesses,” he noted, “due large- ly to significant generic drug introductions and purchasing synergies related to the merg- er [of CVS and Caremark]. “Net earnings climbed 92.6 percent to $2.6 billion. “Although their lower prices depress revenue growth and we continue to see pressure on pharmacy reimbursement rates, generics are more prof- itable than brand name drugs and help drive margin expan- sion,” Ryan added. “More- over, CVS Caremark is now the largest purchaser of gener- ic drugs in the United States, which enables us to drive down costs.” Last year, 63 percent of the scripts filled by CVS were for generic drugs, according to its chairman. And that percent- age, he predicts, will grow higher in the coming years. “With approximately $70 billion in branded drug sales coming off patent in the next five years, we expect that figure to rise to 75 percent by 2012,” Ryan noted. “We should see simi- lar gains for Caremark’s PBM business, whose generic dispensing rate is currently at 60 percent.”

4 • September 2008 www.drugstorenews.com Drug Store News rigine) and pain drug version of ’s block- will lose patent protection. and 2012 is $87 billion, ad- Biosimilars Imitrex (sumatriptan). On buster anti-cholesterol drug The total market for the ding to the $30 billion worth CONTINUED FROM PAGE 1 Nov. 30, 2011, Ranbaxy Lipitor, and over the year drugs facing the risk of gener- of drugs that came off patent der drug Lamictal (lamot- plans to launch a generic after that, 60 more drugs ic competition between 2008 in 2006 and 2007, according to IMS Health data. But the question is, what BEHIND EVERY happens after five years? According to IMS Health data, the value of drugs CONSUMER BUYING DECISION, losing patent protection will drop sharply in 2013, THERE IS A CHAIN OF INFLUENCE. peaking briefly at $20 bil- lion in 2014 and steadily falling thereafter. “[The] majority of the high- ranking branded drugs will be coming off patent prior to 2013, leaving a void in new generics after that,” said Deb- orah Weinswig, managing director and senior retail ana- lyst at Citi Investment Re- search. “Additionally, there have not been any new en- tries of drugs that will be going off patent.” This, Weinswig said, prob- ably will lead to increased competition among generic drug makers as they compete for the same market share after their 180-day marketing exclusivity periods end. The current rush is the result of a boom in drug innovation between the early 1990s and 2001, said Doug Long, vice president of industry relations for IMS Health and an expert on the generics industry. Now, he said, pharmaceutical inno- CONNECT WITH CONFIDENCE. vation has entered a much less productive period. Fromthecornerofficetoeverycornerof retail pharmacy marketplace.* Online, in An environment of ram- thestore,theDrugStoreNewsGroupis print, and at events, the Drug Store News pant price competition could make it harder for yourstrongestlinktothepeoplewhobuy, Groupwillbuildyourbusinessandyour generic drug makers to sell and recommend your products. That’s brands. make a profit. The first man- becauseDrugStoreNewsisthe#1source Call or click PublisherJohnKenlonat ufacturer to win regulatory ofnews,knowledgeandnetworkingfor 212-756-5238/[email protected] approval for a generic drug professionals in the multi-billion dollar to learn more, and sell more. gets first-to-file market exclusivity for 180 days. After that, however, the drug becomes fair game. “This is why margins for THE STRONGEST LINK IN THE CHAIN. generic drugs are so much lower than branded drugs,” Weinswig said. “Branded drugs have 80 percent-plus www.drugstorenews.com gross margin, and generics are nowhere near this. As *Readex Readership Study, August 2008 CONTINUED ON PAGE 6 Drug Store News www.drugstorenews.com September 2008 • 5 tition to increase.” that Wal-Mart started in patients antibiotics for free. For the time being, how- Biosimilars Add to the mix the rapid- 2006 when it began selling “You may see the generics ever, those within the indus- CONTINUED FROM PAGE 5 ly growing number of 30-day supplies of certain market being even more com- try do not appear worried. more drugs come off patent, retailers offering discounts generics for $4, as well as moditized than it already is,” “The generic industry we would expect the compe- on generic drugs, a trend some retailers giving Long said. will continue to pursue ap- proval of generics, as we have over the course of the 25 years since the [Hatch- Waxman Act] created the modern, U.S. generic phar- maceutical industry,” Smart Dermatology. Mayr said, referring to the Drug Price Competition and Patent Term Restor- ation Act of 1984, which opened the door to generic competition by allowing the Food and Drug Administration to approve generic equivalents to branded drugs. Generic drug makers also have a lot of hope for generic biotech drugs, commonly known as bio- generics or biosimilars. The law prohibits the FDA from approving biogener- ics, but that hasn’t stopped companies from trying to develop them. In July, Richmond, Va.- based Insmed announced that its generic version of Amgen’s immune-system boosting drug Neupogen worked as well as the brand-name drug in 32 test subjects. On Aug. 13, The Washington Post published a feature about the compa- ny’s efforts lobbying Congress to allow FDA ap- proval for biogenerics. The company conducted a study, estimating that generic versions of the top 12 categories of biologics We’re focused on doing one thing, At Harris Pharmaceutical, our mission is simple: to provide our whose patents have expired and doing it well. pharmacy partners with the highest quality generic dermatological or will soon expire could save up to $378 billion over products backed by superior customer service. the next 20 years. Long thinks generic drug It is a commitment we bring to every customer relationship and is makers soon could be able to reflected in our expanding portfolio of products — and our growing manufacture and market biogenerics. list of satisfied customers. “There may be some moving into biosimilars To learn more about how our focus can help grow your business, and the more difficult-to- visit us at harrispharmaceutical.com today. make products to try to get higher margins,” he said. “You’re talking 2012, so there’s a reasonable chance that they’ll have the ability CONTINUED ON PAGE 7 6 H•P SeptemberH 12681 Drug S t2008ore News.indd 1 www.drugstorenews.com 8/1/08 2:43:02 PM Drug Store News Biosimilars ing biogenerics go beyond and there’s more variability chemicals to produce com- pounds, a complex process CONTINUED FROM PAGE 6 regulatory approval. in them,” Long said. pounds, making biotech that demands extreme pre- to make those things.” “Biotechnology products While making chemical drugs involves manipulat- cision. The reason they’re But the obstacles to mak- are more difficult to make, drugs involves combining ing cells to produce com- called biosimilars is be- cause the manufacturing process makes it possible to produce two similar com- pounds, but impossible to create two identical ones. Nevertheless, GPhA hopes to clear the way for their approval. “GPhA and its member companies will continue to We help you reach higher. work with Congress to ensure that patients have access to safe, effective and affordable biogeneric medi- cines,” he said. Despite the optimism, Insmed has other prob- lems. The company ann- ounced Sept. 3 that the NASDAQ Listing Quali- Total Management fications Panel had threat- ened to delist it unless it could maintain a closing- bid stock price of at least $1 for 10 consecutive business days by Dec. 15. When you’re managing a chain of pharmacies, being successful Long foresees a wave of takes much more than a pharmacy management system. consolidations taking place QS/1®’s broad array of integrated technology helps manage among generic drug mak- \RXU HQWLUH EXVLQHVV PRUH HI¿FLHQWO\ IURP FHQWUDO ,95 WR VKDULQJ ers. India’s Sun Pharm- aceutical Industries plans data between pharmacies to analyzing pharmacy data. We to buy Israel’s Taro Pharm- NQRZWKHUH¶VPRUHWR\RXUSKDUPDF\¶VVXFFHVVWKDQ¿OOLQJ aceutical Industries, and Japanese-branded drug prescriptions. That’s why you can count on us to help you maker Daiichi Sankyo reach your goals, too. recently bought Ranbaxy Laboratories. If Teva Phar- Our business is helping your business. maceutical Industries fin- alizes its deal to acquire Barr Labs, it will own almost a quarter of the U.S. Learn how QS/1 helps pharmacies like yours at generics market. ZZZFKDLQHI¿FLHQF\TVFRP today. Whatever happens, just as the Gold Rush helped create California’s modern economy, and the tech boom gave rise to the glob- al computer culture, the Generics Rush also could 1-800-231-7776 have a lasting effect on the www.qs1.com drug industry. “I think generics are © 2008, J M SMITH CORPORATION. QS/1 is a registered trademark of the J M Smith Corporation. already changing the phar- maceutical market as more become available,” Long said. “The savings on generics have created head- room for specialty products and current and future innovation.” Drug Store News www.drugstorenews.com September 2008 • 7