28 April 2017 No. 3851 Scripscrip.pharmamedtechbi.com Pharma intelligence | informa However, the US is poised for potentially significant growth in the biosimilar category in the coming year. There currently are at least six 351(k) applications and at least one resubmitted application pending with FDA. The report’s discussion of delivery de- vice, packaging and product dosing con- siderations as market drivers is particularly timely in the context of FDA’s recently re- leased draft guidance on interchangeabil- ity, which suggested that such differences from a reference product could present a hurdle to achieving an interchangeability determination. “While the biosimilar market continues to develop, we expect that the next year will bring another strong phase of growth and market maturity for biosimilars,” Amgen’s Shutterstock: spaxiax Shutterstock: Duane Barnes, vice president and general manager of US Value and Access, said in the report’s opening message. “We anticipate Biosimilar Product Differences Will additional regulatory and legal activity sur- rounding these agents across a range of Affect US Uptake, Amgen Predicts therapeutic areas.” Differences in product characteristics should be considered in formulary decisions, Amgen INDICATION BREADTH says in annual trends report that puts its biosimilars in a strong competitive light while The report discusses the FDA approval path- also bolstering the position of its reference biologics. way for 351(k) applications, evolution of the US biosimilar market, and patient and phy- SUE SUTTER [email protected] sician perceptions of the product category. It also identifies manufacturer, product iosimilar product considerations such The document marks Amgen’s fourth re- and operational considerations that pay- as delivery device, dosing and pack- port on biosimilar trends, but the first since ers and other formulary decision-makers Baging that differ from the reference the company received FDA approval last should take into account when evaluating a product may affect uptake of the follow-on September of its own biosimilar, Amjevita biosimilar and considering appropriate cov- agents in the nascent US market, a new Am- (adalimumab-atto), which references AbbVie erage criteria (see box). gen Inc. report states. Inc.’s TNF-inhibitor Humira (adalimumab). The document reiterates a point raised While a biosimilar must have no clinically The US biosimilars market is still young, in Amgen’s earlier reports regarding supply meaningful efficacy or safety differences with just four approved products. Only two chain reliability and avoiding the potential from the reference product, nonclinical dif- of these – Sandoz Inc.’s Zarxio (filgrastim- for drug shortages when making formulary and prescribing decisions about a biosimi- ferences could have implications for payers, sndz) and Celltrion Inc.’s Inflectra (infliximab- lar. It emphasizes the importance of biologic integrated delivery networks, healthcare dyyb) – have launched; commercialization manufacturing experience. providers and patients, the “2017 Trends in of Amjevita and Sandoz’s Erelzi (etanercept- Biosimilars Report” states. szzs) have been delayed by patent litigation. CONTINUED ON PAGE 8 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE Market Intelligence Research & Development Company Focus Can cholesterol drug sponsors make New active substance launches UniQure gives up on Glybera, but not the case for statin intolerance? (p11) declined again in 2016 (p14) gene therapies (p18) IN THIS ISSUE from the editor [email protected] If a company is still assuming the value of its drug is to stretch the length of significant profitable service almost entirely tied up in the IP around its active ingre- a drug can deliver. For example, while a biologic may dient, it is probably over-zealous in its interpretation of technically be exposed to biosimilar competition, bar- the IP protection bargain between society and innova- riers to adoption are likely to be posed by peripheral tive pharma. At its extreme, this bargain entails generic elements such as the delivery device in which the origi- competition being held at bay for a limited number of nator product is packaged (see cover story). “Beyond the years of premium pricing – to generate funds to plow pill” factors can become even more important in bind- back into novel drug development – and then being ing payers to an out-of-patent branded product if the unleashed to flood the market with the same medicine originator harnesses real-world evidence to ‘accessorize’ at a fraction of the price. This frees up patient spending its offering and demonstrate how patient outcomes dollars and the cycle begins again. associated with the drug are influenced by numerous In fact, the multiple facets of digital health technol- non-pharmacological factors, from delivery devices ogy and the increasing complexity of many therapies and physician education to adherence, monitoring (from biologicals to combinations to respiratory medi- and medical support apps. Now more than ever, patent cines packaged in proprietary inhaler devices) promise expiry need not be a cliff-edge for pharma. 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ISSN 0143 7690. 2 | Scrip intelligence | 28 April 2017 © Informa UK Ltd 2017 NAS Launches Declined In 2016 Amgen’s study supports LDL- Emicizumab’s lowering Next Big 20Challenge 7 11 16 exclusive online content inside: COVER / Biosimilar Product Differences Will Affect US Uptake, Biomunex CEO On Earlier Deals For Cancer Drugs Amgen Predicts http://bit.ly/2pcLp8S Biomunex CEO Pierre Emmanuel Gerard discusses the 4 Veliparib Phase III Failures Strike Blow To AbbVie’s company’s founding, its pipeline of innovative bispecific Oncology Strategy antibodies being developed for oncological indications, and the partnering potential for these compounds. 5 Teva’s AirDuo Authorized Generic Priced At A 70% Discount To Advair Newron CEO On Xadago & Upcoming Pipeline 6 Rebates, Pricing Pressure Weigh On J&J’s 1Q Pharma Sales Milestones http://bit.ly/2on4Ts9 7 Roche’s Emicizumab Progresses Against Hemophilia’s Next Newron CEO Stefan Weber joins Scrip to discuss the company’s Big Challenge recently approved Parkinson’s therapy Xadago (safinamide), as well as development timelines for Newron’s other pipeline 9 High Profile Combo Answer To Late-Stage NASH Programs? candidates. 10 AbbVie Next-Gen Combo To Target Hard-To-Cure Noxxon CEO Talks Partnering Strategy & Cancer HCV Patients Combos http://bit.ly/2pXpdQJ 10 OncoMed Trying To Regroup After Cancer Failures Aram Mangasarian, CEO of Noxxon Pharma, a biotech company focused on cancer therapies targeting the tumor 11 Can Cholesterol Drug Sponsors Make The Case For microenvironment, discusses partnering options and his Statin Intolerance? strategy for how Noxxon can compete in the busy immuno- oncology space. 14 New Active Substance Launches Declined Again In 2016 18 UniQure Gives Up On Glybera, But Not Gene Therapies India Pricing Authority Chief Says List Is No Attempt To Vilify Industry 20 Immune-Focused Discovery Firm Alpine Goes Public http://bit.ly/2oDIh1H The chair of India’s National Pharmaceutical Pricing Authority 21 Valeant Gives Siliq Competitive Price In Crowded has tried to clear the air around the regulator’s recent public Psoriasis Market notice that lists over 600 products suspected of having flouted price caps, telling Scrip the chances of error around the data 22 Pipeline Watch used to verify compliance is low, though at least half a dozen companies on the list indicate they have complied with the regulator’s norms. 23 Multispecific Approach Could Improve I-O Side Effect Profile, Says Numab Forward Pharma Faces Uphill Struggle Appealing 23 Appointments Biogen’s Tecfidera PTAB Win http://bit.ly/2oZAzTp Forward Pharma is suspending all FP187 development pending the outcome of its legal interference appeal against Biogen – but analysts see little prospect of it overturning last month’s decision that effectively allows Biogen’s dimethyl fumarate-based drug Tecfidera to stay on the market with @scripnews /scripintelligence its own patent. /scripintelligence /scripintelligence scrip.pharmamedtechbi.com 28 April 2017 | Scrip intelligence | 3 RESEARCH & DEVELOPMENT Veliparib Phase III Failures Strike Blow To AbbVie’s Oncology Strategy STEN STOVALL