The Landscape of the Biosimilar Market

ISR THE LANDSOCAPE OF THE BIOSIMILAR MARKET A changing world for follow-on biologics An infographic from Industry Standard Research | ISRReports.com WHAT ARE BIOSIMILARS? biosimilars (bīo simələrs) noun - a term used to describe officially approved subsequent (or "generic") versions of innovative biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Low hanging fruit 2009 Between 2009 and 2019 21 blockbuster biopharmaceuticals, mainly in the areas of oncology and inflammatory diseases, will have lost patent protection. $$$$$$$$$$ These 21 blockbuster drugs have a combined annual market value of over 2019 $50 Billion (US). Safety concerns Because the manufacturing process is more complex, biosimilars often come with safety concerns that are not common to generic pharmaceutical products. Physicians, Pharmacists and Payers have different opinions regarding the safety of biosimilars. ISR asked each group if biosimilars should require full-fledged clinical trials. Pharmacists Physicians 55% Yes Payers 26% Yes 10% Yes Legislation In its "Draft Guidance" the FDA has stated that biosimilars must be "interchangeable"; however final guidance has not yet been provided. State legislatures have seen an influx of bills on biosimilars in the past two months, but the details vary. PHYSICIAN NOTIFICATION Most bills require the pharmacist to notify the prescribing physician of a biosimilar switch, but the timelines for notification vary. 124 hours 15 days 13 days 10 days Bill in process, but no mention of physician notification timeline RECORD RETENTION Most bills require the pharmacy to retain a record of the biosimilar switch, but the length of time varies. 1 2 years 1 5 years 7 years 3 years 4 years years Bill in process, but no mention of record retention timeline Key Players and Partnerships The pharmaceutical and biotech industry is forming alliances and partnerships for the development of biosimilar drugs. Here is just a portion of the web of alliances. CRO/CMO GENERIC OBIOPHARMA OTHER TEVA WOCKHARDT DESANO PHARMA BIOCON CIPIA EMCURE WATSON ROCHE ELI LILLY JOHNSON & JOHNSON STADA GENEN- TECH HOSPIRA AMGEN CELLITRON MERCK PAREXEL DR. REDDY HANWHA SAMSUNG INTAS QUINTILES BIOGEN IDEC CATALENT SANDOZ UMN PFENEX PHARMA RANBAXY SOURCES: Industry Standard Research (Biosimilar Primer Series) http://www.parexel.com/services-and-capabilities/consulting/biosimilars/ Nick, C (2012). "The US Biosimilars Act: Challenges Facing Regulatory Approval". Pharm Med 26 (3): 145–152. http://www.sandoz-biosimilars.com/sandoz_biosimilars/index.shtml http://www.somatropin.net/hgh-brands.htm http://seekingalpha.com/article/227373-hospira-receives-aus- tralian-approval-for-nivestim http://www.thepharmaletter.com/file/16503/sta- da-cleared-to-market-epo-zeta-in-eu.html http://www.drreddys.com/products/product-portfolio.html http://www.prnewswire.com/news-releases/hospira-celltrion-en- ter-business-cooperation-agreement-to-develop-and-market-biogeneric-drugs-63 765702.html www.openstates.org ISR [email protected] @ISRREPORTS ISRREPORTS.COM reports