Biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company, when the original product's patent expires. Biosimilar products are obtained from living organisms such as animals, humans, and microorganisms through biotechnology. They are also derived from natural sources or produced synthetically. Biosimilar is mostly used in treatment of diabetes, rheumatoid arthritis, anemia, inflammatory bowel disease, multiple sclerosis, low white blood cell counts, psoriasis and various forms of cancer. Furthermore, biosimilar products are similar to original product but have allowable differences as derived from living organisms with no clinical differences in terms of purity, safety, and potency. The market is driven by factors such as cost-effectiveness of biosimilar drugs, owing to the decrease in the financial burden on patients, as well as reimbursement service providers. Furthermore, due to the high prevalence of chronic diseases such as rheumatoid arthritis, diabetes, anemia, low white blood cell counts, inflammatory bowel disease, multiple sclerosis, psoriasis and various forms of cancer. For instance, according to the National Cancer Institute (NCI), in 2018, around 1,735,350 new cases of cancer were diagnosed and 609,640 people died from the disease. In U.S., the first biosimilar product, approved by FDA in 2015, Sandoz’s Zarxio, is a biosimilar version of filgrastim for the treatment of neutropenia, and almost 9 years after the EU approved the launch of Sandoz’s for human growth hormone Omni trope. Furthermore, strict government regulations for the development and production of biosimilar could restraint biosimilar market growth. Furthermore, the development and manufacture of biosimilars are more time consuming as compared to generics. Biosimilar takes around 7-8 years for its development, with high financial investments ranging between USD 100 million and USD 300 million. Recombinant non-glycosylated proteins include granulocyte colony-stimulating factor, interferons, insulin, and human growth hormone. Recombinant non-glycosylated proteins was the largest revenue generating segment owing to the increased regulatory approvals of biosimilar in 2016. For instance, the European Medicines Agency approved three Basimilar drugs in November: Lusduna and Movymia and Terrosa. Moreover, growing prevalence of chronic diseases such as diabetes, cancer, arthritis, Alzheimer’s disease, chronic kidney disease, and chronic pain is expected support the growth of the biosimilar market. For instance, according to Centers for Disease Control and Prevention (CDC), in 2016, approximately 29.0 million people were suffering from diabetes. The oncology application segment is leading segment for biosimilars market. This is attributed to increasing incidence of cancer including lung, liver, colorectal, stomach, breast, and blood cancer. According to the World Health Organization (WHO), cancer is the second leading cause of deaths around the world. Europe accounted for the largest share, owing to presence of well-defined regulatory framework for biosimilars and major biopharmaceutical companies such as Johnson & Johnson, AstraZeneca, Novartis, Pfizer, Sanofi, Merck, and GlaxoSmithKline. In addition, well established healthcare infrastructure and developing number of new product is boosting growth of the market. Key players are focus on collaborations, mergers and acquisitions, new drug developments, and regional expansions to strengthen their market positions. For instance, in October 2016, Celltrion Healthcare and Teva Pharmaceutical Industries Ltd. entered into a strategic partnership to commercialize CT-P10 and CT-P6 in U.S. and Canada. In November 2017, Samsung Bioepis Co. Ltd received approval from European Commission marketing approval for Ontruzant, a biosimilar for trastuzumab, for the treatment of breast cancer. At the same time, the company received the approval for Samfenet and Herceptin to be sold in South Korea. In December 2017, Pfizer received the approval from US FDA for infliximab biosimilar, for all eligible indications, while Mylan received the US FDA approval for Ogivri, the first biosimilar for trastuzumab, co-developed with Biocon.
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