Mylan Launches Gilead Sciences' Sovaldi® Tablets in India

Total Page:16

File Type:pdf, Size:1020Kb

Mylan Launches Gilead Sciences' Sovaldi® Tablets in India May 4, 2015 Mylan Launches Gilead Sciences' Sovaldi® Tablets in India POTTERS BAR, England and HYDERABAD, India, May 4, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched Gilead Sciences' Sovaldi (sofosbuvir 400mg tablets) in India. Sovaldi is indicated for the treatment of chronic hepatitis C infection, a blood-borne infectious disease, as a component of a combination antiviral treatment regimen. It is estimated that approximately 12 million people are chronically infected with hepatitis C in India. In February 2015, Gilead appointed Mylan as its exclusive distributor of Sovaldi in India. Mylan President Rajiv Malik commented, "Mylan has a long-standing history of partnering with Gilead to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending our partnership to include hepatitis C treatments. We are proud to continue our work together with the launch of Sovaldi as it supports our joint commitment to meeting the unmet medical needs of patients in India." "We are pleased to bring this important therapeutic advance to patients living with hepatitis C in India. Today marks an important milestone in Gilead's ongoing effort to make its hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible," said Gregg Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences. Sovaldi is sold by Mylan's dedicated sales force as part of its Hepato Care segment. Additional hepatitis C arrangements with Gilead include: ● A licensing and technology transfer agreement that grants Mylan the non-exclusive rights to manufacture and distribute generic sofosbuvir and generic ledipasvir/sofosbuvir and, upon FDA approval, the investigational NS5A inhibitor GS- 5816 and single tablet regimen of sofosbuvir/GS-5816 in 91 developing countries ® ● An exclusivity for distribution of Gilead's brand Harvoni (ledipasvir 90mg/sofosbuvir 400 mg tablets) in India This press release includes statements that constitute "forward-looking statements," including with regard to sales of products, product approvals and the company's strategy, future growth and performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impacts of competition; changes in economic and financial conditions of the company's business; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; risks associated with international operations; uncertainties and matters beyond the control of management; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release. Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com Sovaldi® and Harvoni® are registered trademarks of Gilead Sciences Photo - http://photos.prnewswire.com/prnh/20150501/213323 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mylan-launches-gilead-sciences- sovaldi-tablets-in-india-300076220.html SOURCE Mylan N.V. News Provided by Acquire Media.
Recommended publications
  • Responding to Mylan's Inadequate Tender Offer
    Responding To Mylan’s Inadequate Tender Offer: Perrigo’s Board Recommends That You Reject the Offer and Do Not Tender September 2015 Important Information Forward Looking Statements Certain statements in this presentation are forward-looking statements. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control, including future actions that may be taken by Mylan in furtherance of its unsolicited offer. These and other important factors, including those discussed under “Risk Factors” in the Perrigo Company’s Form 10-K for the year ended June 27, 2015, as well as the Company’s subsequent filings with the Securities and Exchange
    [Show full text]
  • J. SCOTT MCBRIDE PARTNER ━ 54 West Hubbard Street, Chicago, IL 60654 | 312.494.4436 | [email protected]
    J. SCOTT MCBRIDE PARTNER ━ 54 West Hubbard Street, Chicago, IL 60654 | 312.494.4436 | [email protected] EDUCATION & HONORS The University of Chicago Law School, 2002, J.D., with High Honors Order of the Coif 1st Place, Hinton Moot Court The University of Chicago Law Review Northwestern University, 1994, M.S. Ed., Earned Illinois Secondary Teaching Certificate for Chemistry, Physics and German Dartmouth College, 1992, A.B., summa cum laude, High Honors in Chemistry Phi Beta Kappa Rufus Choate Scholar German Academic Exchange Service Scholarship Chandler T. White Chemistry Research Prize CLERKSHIPS Honorable Richard D. Cudahy, United States Court of Appeals for the Seventh Circuit, 2002-2003 ADMISSIONS Illinois INTELLECTUAL PROPERTY LITIGATION ViiV Healthcare v. Gilead Sciences (D. Del.) Lead trial counsel for Gilead in patent infringement case related to Gilead's Biktarvy® HIV treatment. Case pending. www.bartlit-beck.com CHICAGO 312.494.4400 DENVER 303.592.3100 J. SCOTT MCBRIDE Adverio Pharma GmbH v. Alembic Pharmaceuticals, Ltd. et al. (D. Del.) Lead trial counsel for Adverio and Bayer in Hatch-Waxman litigation relating to Bayer's Adempas® (riociguat) treatment for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Gilead Sciences v. Mylan Pharmaceuticals (D. Del.) Lead trial counsel for Gilead in Hatch-Waxman litigation relating to Gilead's Tybost® (cobicistat) product. Case settled favorably. UroPep v. Eli Lilly (E.D. Tex.) Lead trial counsel (with my partners John Hughes) for UroPep in patent infringement action related to Lilly's Cialis product. Trial verdict for UroPep with damages of $20 million; affirmed on appeal. Regents of the Univ.
    [Show full text]
  • Pfizer and Mylan Will Own 57% and 43% of the New Company (“Newco”), Respectively
    DEAL PROFILE PFIZER | MYLAN VALUES 57% 43% $12.0bn PFIZER SHARE OF NEWCO MYLAN SHARE OF NEWCO NEW DEBT RAISED Pfizer Inc. (NYSE:PFE) Pfizer Inc. (“Pfizer”) is a pharmaceutical company that develops, manufactures, and sells products in internal medicine, vaccines, oncology, inflammation & immunology, and rare diseases. Upjohn, a subsidiary of Pfizer, is composed of Pfizer’s oral solid generics and off-patent drugs franchise, such as Viagra, Lipitor, and Xanax. Upjohn has a strong focus in emerging markets, and is headquartered in Shanghai, China. TEV: $265.4bn LTM EBITDA: $22.5bn LTM Revenue: $55.7bn Mylan N.V. (NASDAQ:MYL) Mylan N.V. (“Mylan”) is a pharmaceutical company that develops, manufactures, and commercializes generic, branded-generic, brand-name, and over-the-counter products. The company focuses in the following therapeutic areas: cardiovascular, CNS and anesthesia, dermatology, diabetes and metabolism, gastroenterology, immunology, infectious disease, oncology, respiratory and allergy, and women’s health. Mylan was founded in 1961 and is headquartered in Canonsburg, PA. TEV: $23.9bn LTM EBITDA: $3.5bn LTM Revenue: $11.3bn Bourne Partners provides strategic and financial advisory services to BOURNE clients throughout the business evolution life cycle. In order to provide PARTNERS the highest level of service, we routinely analyze relevant industry MARKET trends and transactions. These materials are available to our clients and partners and provide detailed insight into the pharma, pharma services, RESEARCH OTC, consumer health, and biotechnology sectors. On July 29, 2019, Pfizer announced the spin-off of its off-patent drug unit, Upjohn, in order to merge the unit with generic drug manufacturer, Mylan.
    [Show full text]
  • Mylan Signs Agreement with Gilead to Enhance Access to Tenofovir Alafenamide (TAF)- Based HIV Treatments in Developing Countries
    December 1, 2014 Mylan Signs Agreement with Gilead to Enhance Access to Tenofovir Alafenamide (TAF)- based HIV Treatments in Developing Countries PITTSBURGH and HYDERABAD, India, Dec. 1, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences, Inc. under which Mylan has licensed the non-exclusive rights to manufacture and distribute Tenofovir Alafenamide (TAF) as both a single agent product and in combination with other drugs. Tenofovir Alafenamide (TAF) is an investigational antiretroviral drug for the treatment of HIV-1 infection. The license being granted to Mylan extends to 112 countries, which together account for more than 30 million people living with HIV, representing 84% of those infected globally.1 Mylan CEO Heather Bresch said, "Mylan's mission is to provide the world's 7 billion people access to high quality medicines and set new standards in health care. By working with partners like Gilead to help ensure access to innovative new products such as Tenofovir Alafenamide (TAF) in the countries hardest hit by this disease, we can help stem the tide of HIV/AIDS around the world." As part of the licensing agreement, on U.S. Food and Drug Administration (FDA) approval, Mylan will receive a technology transfer from Gilead, enabling the company to manufacture low-cost versions of Tenofovir Alafenamide (TAF), if approved as a single agent or in approved combinations containing Tenofovir Alafenamide (TAF) for developing markets. Phase III trials by Gilead Sciences met their primary objective supporting the potential for Tenofovir Alafenamide (TAF) to provide a new treatment option for individuals living with HIV.
    [Show full text]
  • Faculty Disclosure
    Faculty Disclosure In accordance with the ACCME Standards for Commercial Support, course directors, planning committees, faculty and all others in control of the educational content of the CME activity must disclose all relevant financial relationships with any commercial interest that they or their spouse/partner may have had within the past 12 months. If an individual refuses to disclose relevant financial relationships, they will be disqualified from being a part of the planning and implementation of this CME activity. Owners and/or employees of a commercial interest with business lines or products relating to the content of the CME activity will not be permitted to participate in the planning or execution of any accredited activity. Nature of Relevant Financial Relationship Last Name Commercial Interest What Was Received For What Role AbbVie, Allergan/ Tobira Therapeutics Inc, Gilead Research Grant Research Balart Sciences Inc, Pfizer, Salix Pharmaceuticals AbbVie, Merck Honorarium Advisory Board Bau None N/A N/A Benz None N/A N/A AbbVie, Arbutus Biopharma, Dieterich Gilead Sciences, Inc., Bristol- Research Grant Consultant Myers Squibb, Merck Bayer HealthCare Pharmaceuticals, Gilead Sciences Honorarium Speaking, Consultant Inc. Bristol-Myers Squibb, Gilead Speaking, Advisory Sciences, Inc, Salix Honorarium Frenette Board Pharmaceuticals, Inc, Merck Intercept Pharmaceuticals Honorarium Advisor Conatus Pharmaceuticals Inc Honorarium Consulting Principle Investigator, Research Grant, Han Gilead Sciences,
    [Show full text]
  • 1976 3M Medical Solutions Division 2019 Electrocore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc
    CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Solutions Division 2019 electroCore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc. 2010 Endo Pharmaceuticals 2018 Organogenesis 2013 AbbVie Inc. 2017 Exelixis 2004 Otsuka America Pharmaceutical, Inc. 2021 Adaptive Biotechnologies 2016 Express Scripts Federal Pharmacy 2018 Pacira BioSciences, Inc. 2017 ACADIA Pharmaceuticals, Inc. 2010 Federal Practitioner 2018 Paratek Pharmaceuticals 2020 AcelRx Pharmaceuticals, Inc. 2018 Foundation Medicine, Inc. 1990 Pfizer Pharmaceuticals 2020 Acorda Therapeutics 2021 Frontier Technology Inc. (FTI) 2017 Pharmacyclics, LLC 2019 Aimmune 2020 Fresenius Medical Care North America 2020 RedHill BioPharma 2003 Alcon Laboratories, Inc. 1989 Genentech Inc. 2019 Red One Medical 2019 Alexion Pharmaceuticals, Inc. 2006 Gilead Sciences 2020 Regeneron 2017 Alkermes, Inc. 1983 GLAXOSMITHKLINE 2009 Regenesis Biomedical, Inc. 2019 Alnylam Pharmaceuticals 2013 Golden State Medical Supply, Inc. 2011 Remund Group, LLC 2019 Altarum Institute 2020 GRAIL 2018 Rigel Pharmaceuticals 2020 Amarin Corporation 2019 Greenwich Biosciences 2000 Sanofi 1994 AmerisourceBergen 2013 Gulf Coast Pharmaceuticals Plus, LLC 2020 Seattle Genetics 1992 Amgen 2008 Heritage Health Solutions, Inc. 2004 Siemens Medical Solutions 2020 Amneal Pharmaceutical 2017 Hill-Rom Company 2019 SK Life Science, Inc. 2019 Aptive Resources LLC 2020 Immunomedics 2002 Smith & Nephew, Inc. 2020 The Arbinger Institute 2019 ImmunoVation, LLC 2019 Sobi Inc. 2011 Arbor Pharmaceuticals, LLC 2019 Incyte Corporation 2013 Stryker Orthopaedics 2010 Argentum Medical, LLC 2019 Indivior 2018 Sun Pharmaceutical 2019 ASM Research, LLC 2015 Intercept Pharmaceuticals 1999 Sunovion Pharmaceuticals, Inc. 1986 Astellas Pharma US, Inc. 2019 Ipsen Biopharmaceuticals, Inc. 2016 Taiho Oncology, Inc. 1995 AstraZeneca 2018 IT Cadre 2015 Takeda Oncology 2020 Baudax Bio, Inc.
    [Show full text]
  • COVID-19 Pharmacotherapy MATTHEW F
    COVID-19 Pharmacotherapy MATTHEW F. DERAEDT, PHARM.D., B.C.P.S. ANMC EMERGENCY DEPARTMENT PHARMACIST LT, USPHS Disclosure •No conflicts of interest to disclose •Recommendations to follow primarily from Alaska Native Medical Center’s Policy and Procedures •Clinical questions regarding specific patients should be deferred to ANMC Infectious Disease Department •Rapidly evolving FDA EUA and approved indications Objectives •Understanding inclusion and exclusion criteria for COVID-19 pharmacotherapies •Mechanism of action (MOA), pharmacokinetics, and pharmacodynamics for various therapies •Monitoring parameters for pharmacotherapies •Regulatory requirements for emergency use authorization therapies Remdesivir (Veklury®) •Adenosine nucleotide analog prodrug that is metabolized intracellularly to a nucleoside monophosphate intermediate •The nucleoside monophosphate is phosphorylated to active compound nucleoside triphosphate metabolite •The remdesivir- triphosphate (RDV TP) competes with ATP for incorporation into nascent RNA chains by SARS-CoV-2 RNA Dependent RNA Polymerase (RdRp) •Inhibits RNA chain termination Adamsick ML, et al. JASN. 2020:31(7):1384 - 1386 Remdesivir [package insert]. Foster City, CA. Gilead Sciences Inc. 2020. Road To Approval •FDA released on Emergency Use Authorization (EUA) May 1, 2020 •FDA approval on October 22, 2020 for adult patients and pediatric patients 12 years of age or older weighing at least 88 lbs (40kg) for the treatment of hospitalized COVID-19 patients •No longer need to follow EUA requirements for the approved patient population •Three Clinical Trials 1. NIAID ACTT-1: Mild/moderate and Severe COVID-19 2. GS-US-540-5774: Moderate COVID-19 3. GS-US-540-5773: Severe COVID-19 Remdesivir [package insert]. Foster City, CA. Gilead Sciences Inc. 2020. Spinner CD, et al.
    [Show full text]
  • Merck & Co., Inc
    As filed with the Securities and Exchange Commission on February 25, 2021 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2020 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth New Jersey 07033 (908) 740-4000 New Jersey 22-1918501 (State or other jurisdiction of incorporation) (I.R.S Employer Identification No.) Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol(s) Name of Each Exchange on which Registered Common Stock ($0.50 par value) MRK New York Stock Exchange 1.125% Notes due 2021 MRK/21 New York Stock Exchange 0.500% Notes due 2024 MRK 24 New York Stock Exchange 1.875% Notes due 2026 MRK/26 New York Stock Exchange 2.500% Notes due 2034 MRK/34 New York Stock Exchange 1.375% Notes due 2036 MRK 36A New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2021: 2,530,315,668. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2020 based on closing price on June 30, 2020: $195,461,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
    [Show full text]
  • Fellow Shareholders, Since Perrigo Company
    Fellow Shareholders, Since Perrigo Company plc (NYSE and TASE: PRGO) rejected Mylan N.V.’s (NASDAQ: MYL) unsolicited offer, I have spent a great deal of time speaking with our shareholders and sharing our views on why Mylan’s offer substantially undervalues Perrigo. We are confident in our bright prospects and firmly convinced of the standalone value of Perrigo. I have also engaged with you not only about value, but also about the right way to run a company. I have always believed that good corporate governance creates value for shareholders while bad corporate governance can destroy it. Since becoming the CEO of the Perrigo Company, I have had the privilege of working alongside a Board that shares my commitment to shareholder value creation and sound corporate governance. Together, we believe deeply in our responsibility to shareholders, who are Perrigo’s true owners, and in our obligation to build sustainable, long-term value, which informs everything we do. This commitment has rewarded Perrigo shareholders with a total return exceeding 970 percent since 2007. I have watched with increasing distress the contrast in attitude to shareholders and governance principles that Mylan has presented in its pursuit of Perrigo. Our Board has considered Mylan’s offer in good faith and we have been earnest and straightforward in explaining why we think it substantially undervalues Perrigo and creates significant risks. We have also engaged with you to explain how Perrigo’s ‘Base Plus, Plus, Plus’ strategy is poised to continue to create value in the future for our shareholders. In recent weeks, it has become clear to me that Mylan’s pursuit of Perrigo at all costs has further highlighted some very troubling corporate governance values.
    [Show full text]
  • COVID-19 Therapies and Vaccine Landscape
    editorial COVID-19 therapies and vaccine landscape Within a few weeks of the novel coronavirus genome sequence being published, numerous therapies and vaccines have entered clinical trials with a few showing great promise in alleviating symptoms and accelerating recovery. n late 2019, patients presenting with viral next-generation vaccine development can be pneumonia were reported in Wuhan, expedited by utilizing sequence information IChina, and a novel coronavirus was alone rather than relying on in vitro cultures quickly identified as the causative pathogen of live viruses. Nucleic acid-based vaccines that leads to severe acute respiratory that use this next-generation approach have syndrome (SARS-CoV-2) or COVID- been the frontrunners for COVID-19. One 19. The widely reported unpredictability such example is an mRNA vaccine (mRNA- of the disease means that some infected 1273 — encoding for the virus spike protein individuals are asymptomatic, some have used by viruses to latch onto human host mild flu-like symptoms, whereas other cells) developed by Moderna Therapeutics unfortunate individuals suffer from major and the National Institutes of Health has complications. The lower respiratory tract is already shown promising signs and is the main target for severe symptoms, where Credit: Andrey Deryabin/Alamy Stock Photo currently finalizing preparations for phase high virus shedding has been observed. The III clinical trials7. Another frontrunner body defends itself by an elevated immune in phase IIB/III clinical trials, ChAdOX1 response
    [Show full text]
  • Pharma: Strategic Realignment for a 112/113 Better Future Prism / 2 / 2020
    Pharma: Strategic realignment for a 112/113 better future Prism / 2 / 2020 Pharma: Strategic realignment for a better future ... and how the industry will be forced to overcome its hesitation to innovate in operations Ben van der Schaaf, Aurelien Guichard The life sciences sector faces significant impact from Amid the search for COVID-19 – and although the race for treatments and vaccines effective COVID-19 treatments and vaccines, is dominating the headlines, the effect on the industry will the pandemic will have not solely be positive. long-term side effects for the global pharmaceutical In the short term, some companies industry. As our article explains, companies are laying people off and reducing will need to focus on operations, whereas others are change in three areas reallocating resources to focus on (portfolio reprioritization, COVID-19, or even ramping up accelerated R&D and technology efforts in other areas. Stock-market transformation) if they performance has been as diverse are to position (Figure 1). themselves successfully for the future. Organizations need to consider major strategic questions now, to ensure their success in the longer term. The industry is clearly in the middle of the efforts to combat COVID-19: - More than 20 companies are trying to find a treatment with either new or approved drugs1. - More than 15 companies globally are mobilizing resources to develop new vaccines2. - Globally, by the end of May, more than 1,300 clinical trials related to COVID-19 were recruiting patients3. 1. Marketwatch.com, 6 May 2020 2. Drugtargetreview.com, 9 April 2020 3. clintrials.gov, 31 May 2020 Pharma: Strategic realignment for a 114/115 better future Prism / 2 / 2020 2.
    [Show full text]
  • 1:19-Cv-02226 Document #: 1 Filed: 04/01/19 Page 1 of 74 Pageid #:1
    Case: 1:19-cv-02226 Document #: 1 Filed: 04/01/19 Page 1 of 74 PageID #:1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS WELFARE PLAN OF THE INTERNATIONAL UNION OF OPERATING ENGINEERS LOCALS 137, 137A, 137B, 137C, 137R, on behalf of itself Civil Action No.______________ and all others similarly situated, CLASS ACTION Plaintiff, v. JURY TRIAL DEMANDED ABBVIE INC., ABBVIE BIOTECHNOLOGY LTD, and AMGEN INC., Defendants. CLASS ACTION COMPLAINT Case: 1:19-cv-02226 Document #: 1 Filed: 04/01/19 Page 2 of 74 PageID #:2 TABLE OF CONTENTS I. INTRODCUTION ...............................................................................................................1 II. PARTIES .............................................................................................................................3 III. JURISDICTION AND VENUE ..........................................................................................5 IV. THE REGULATORY FRAMEWORK OF BIOLOGICS ..................................................6 A. Cost Concerns Prompt Congress to Enact the Biologics Price Competition and Innovation Act ..............................................................................6 1. New biologic drug approval under the BPCIA ............................................7 2. Biosimilar drug approval under the BPCIA .................................................8 3. Biosimilar entrants’ effect on marketplace ..................................................9 B. Patent Challenges Under the BPCIA .....................................................................11
    [Show full text]