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How Risky Is Pfizer's Launch of Its Remicade Biosimilar?

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How Risky Is Pfizer's Launch of Its Remicade Biosimilar? REGUlaTORY UPDATE REIMBURSEMENT NEW PRODUCTS Cuba: A Pharmaceutical Regulatory Tagrisso Funding Journey Shows Lilly’s Lartruvo Scores Broad FDA Snapshot, p. 10 UK’s Revamped Cancer Drugs Fund Approval In Orphan Sarcomas, p. 9 Is No Soft Touch, p. 17 Pharma intelligence Pinkpink.pharmamedtechbi.comSheetVol. 78 / No. 43 October 24, 2016 informa The second patent, No. 7,598,083, cov- How Risky Is Pfizer’s Launch Of ers particular compositions of cell culture media that are used to grow the living cells that produce biologics such as inf- Its Remicade Biosimilar? liximab. That patent, issued in October BRENDA SANDBURG [email protected] 2009, expires on Feb. 7, 2027. A jury trial is scheduled to begin on Feb. 13, 2017 to determine if the patent is valid and, if so, whether Inflectra infringes it. Janssen said it would seek damages and royalties on future sales if the court finds that the ‘083 patent is valid and infringed. The trial will also determine if Janssen is entitled to a permanent injunction and whether Celltrion and Pfizer followed the litigation provisions of the Biologics Price Competition and Innovation Act. TREBLE DAMAGES SEEM UNLIKELY Janssen filed two suits against Celltrion, which have been consolidated. The first complaint, filed in March 2015, claims Celltrion infringed several patents and Shutterstock: PHOTOCREO Michal Bednarek PHOTOCREO Shutterstock: failed to provide manufacturing process information for the Inflectra biosimilar in elltrion Inc. and partner Pfizer Inc. factor inhibitor, in late November, nearly violation of the BPCIA. The second com- knocked out one of Janssen Biotech eight months after FDA’s April 5 approval. plaint, filed on June 14, alleges actual acts CInc.’s Remicade (infliximab) patents Janssen issued a release in response saying of infringement of the ‘083 patent based in district court and are betting they will it considered this to be an “at-risk” launch. on new information about the cell culture win a ruling of non-infringement of a cell The risk centers around two of Janssen’s media that was custom made for Celltrion culture media patent. But even if they don’t patents. Massachusetts District Court Judge by HyClone Laboratories Inc. prevail, they may rake in far more in rev- Mark Wolf ruled in August that patent No. Janssen seeks a preliminary and/or per- enues from an Inflectra biosimilar launch 6,284,471, which covers the infliximab anti- manent injunction prohibiting Celltrion than would pay out in potential damages. TNF antibody, is invalid for obviousness- and its partners from making, using or sell- Pfizer announced on Oct. 17 that it would type double patenting. Janssen said it is ing the cell culture media and/or a biosimi- begin shipping Inflectra (infliximab-dyyb), in the process of filing an appeal to the US lar product made with the media, as well its biosimilar to Janssen’s tumor necrosis Court of Appeals for the Federal Circuit. CONTINUED ON PAGE 4 BROUGHT TO YOU BY THE EDITORS OF SCRIP REGULATORY AFFAIRS, THE RPM REPORT, TAN SHEET, GOLD SHEET, PINK SHEET DAILY AND PINK SHEET Maximize Your Reimbursement Potential The balance of power behind the prescribing decision is changing: payers are ever more in charge. That means that insight into how payers make decisions – how they evaluate drugs, one against another – will be crucial to any successful drug launch. RxScorecard objectively, authoritatively, and systematically assesses marketed and pipeline drugs in a therapeutic indication from the payer’s point of view. Developed by senior medical and pharmacy leaders from major payers and pharmacy benefit managers, RxScorecard delivers practical and powerful insight into your drug’s reimbursement potential and how you can maximize it. Transparent, objective, and grounded in payer data, RxScorecard helps you refine your development path, future-proof your market access strategy, and achieve payer acceptance. Discover RxScorecard today. Visit https://goo.gl/mIof2t to review the selection of RxScorecards today. Interact with the data. Compare drugs on clinical, safety, and economic metrics. See the payer perspective. cover 5 13 exclusive online content inside: COVER How Risky Is Pfizer’s Launch Of Its Remicade Biosimilar? CHMP’s October Recommendations Include Venclyxto, Opdivo, Lucentis REIMBURSEMENT http://bit.ly/2dqCFab 20 What Is An Acceptable Drug Discount? The European Medicines Agency’s Committee for Medicinal DOJ and Industry Disagree Products for Human Use (CHMP) meets monthly to review 17 Tagrisso Funding Journey Shows UK’s Revamped applications for centralized EU marketing authorization. Here is Cancer Drugs Fund Is No Soft Touch a summary of their October recommendations. NEW PRODUCTS 9 Lilly’s Lartruvo Scores Broad FDA Approval China Approval Watch: September Dominated In Orphan Sarcomas By Generics And Vaccines 8 FDA’s NDA And BLA Approvals: Tecentriq, Lartruvo, Evzio http://bit.ly/2ebKmmv Twenty-three chemical drugs, three biologics and one traditional ADVISORY COMMITTEES Chinese medicine are among the latest approvals granted by the 6 Allergan’s Nasal Spray For Frequent Nighttime Urination China FDA, which is continuing on a hiring spree to increase its Gets Cautious Panel Nod number of reviewers. 26 Recent And Upcoming FDA Advisory Committees Roadmap On Improvements To EMA’s Literature GENERIC DRUGS Monitoring Service Due By Year End 14 Generic Drug User Fees Will Jump More Than 50% http://bit.ly/2dsV2q4 In FY 2018 The European Medicines Agency will be looking for quick wins as 16 FDA Pushing Forward With Withdrawal well as long-term improvements when it revises its medical literature Of Two Concerta Generics monitoring service. It will soon publish a roadmap for improving the 25 FDA’s ANDA Approvals service with details of when the changes might occur. INTELLECTUAL PROPERTY FDA’s Opioid Crisis Response: More Pressure 24 Does India’s Perpetual Licensing Plan Risk Backfiring? For Treatment Drugs REGULATORY UPDATE http://bit.ly/2dDj70L 10 Cuba: A Pharmaceutical Regulatory Snapshot Sharp increases in deaths from illicit drugs (heroin and synthetic opioids) could change FDA’s priorities; rather than working with 23 EFPIA Urges Japan To Consider New Funding Models drug sponsors on more tamper-deterrent formulations of pain therapies, the agency may need to devote more attention to BIOSIMILARS overdose treatments like naloxone. 5 Biosimilar Clinical Trials Face Enrollment Challenges MANUFACTURING QUALITY ‘Standardized’ Comment From Brexit Minister Raises 11 Despite Progress, More Work Needed To Harmonize Hopes For Parallel EU/UK Drug Approval System FDA and EMA Criteria For Biowaivers http://bit.ly/2enZd8B 13 FDA Outlines Criteria For Approving Manufacturing The way in which pharmaceuticals might be regulated in the UK Supplements Under GDUFA after the country leaves the EU is a big unknown. As MPs get to have their say on the matter, the Pink Sheet tries to gauge CONSUMER PRODUCTS government thinking. 21 Benefit From OTC Switches Supported In Study Of PPIs’ Outpatient Impact pink.pharmamedtechbi.com October 24, 2016 | Pink Sheet | 3 BIOSIMILARS CONTINUED FROM COVER similar version of Amgen’s Neulasta (peg- as trebled damages. filgrastim). Amgen is asserting infringe- In a Sept. 27 joint pretrial memorandum, ment of the ‘878 patent and patent No. Janssen said it would show that Celltrion 5,824,784. Sandoz asserted counterclaims and Pfizer infringed the patent claims Pfizer has already won seeking a declaratory judgment of invalid- either literally or under the doctrine of ity and noninfringement of both patents. equivalents, whereby elements of the in- half the battle since A trial is scheduled for the week of Dec. 11, fringing product are not identical to the 2017 or at the court’s convenience. patented invention but equivalent to it. the district court Janssen said it would also show that the found the ‘471 patent BIOSIMILAR PRICING IS NEXT formula for the defendants’ cell culture FRONTIER media contains every ingredient required invalid. If the Federal As the court battles continue, there is in- by the patent claims. The patent calls for creased focus on biosimilar pricing. Pfizer 52 required ingredients and nine optional Circuit were to reverse, said Inflectra would be introduced at a ingredients. Janssen could not 15% discount to the current wholesale For their part, Celltrion and Pfizer said acquisition cost of Remicade, before any they will show their product does not in- discounts, which equates to $946.28 per argue Pfizer had 100mg vial. fringe literally or under the doctrine of At an Oct. 18 meeting on the future of equivalents. They stated that Janssen has no good faith basis the US biosimilars market held in Washing- not alleged literal infringement and has ton, DC, Lawrence LaMotte, of the Immune been proceeding under the doctrine of to launch. Deficiency Foundation, expressed concern equivalents. that patients will be switched en masse Shashank Upadhye, of Amin Talati Upad- to biosimilars for cost reasons rather than hye, said Pfizer has already won half the clinical reasons. battle since the court found the ‘471 pat- ZARXIO INFRINGEMENT SUIT He alluded to CVS Health Corp.’s decision ent invalid. If the Federal Circuit were to MOVES FORWARD to remove Amgen’s Neupogen and Sano- reverse and the case went back to district Pfizer’s decision to pursue an at-risk launch fi’s glargine insulin Lantis from coverage in court to determine liability, he said Janssen mirrors that of Sandoz Inc., which opted to its national formulary in 2017. could not argue Pfizer had no good faith launch Zarxio (filgrastim-sndz), its biosimi- “This is all about costs,” LaMotte said. “I basis to launch and was liable for treble lar to Amgen Inc.’s Neupogen (filgrastim), find it interesting that with generics, the damages given Wolf’s ruling on the patent. before the resolution of a patent infringe- small molecules, we’ve been talking about With regard to the ‘083 patent, Upadhye, ment suit.
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