Biosimilar is a biological medicine similar to already approved Biological Innovator medicine also known as reference medicine. It may not require extensive clinical trials and testing as required in the case of biologics. The regulatory approval mechanism is different for US, Europe, APAC, and RoW regions. In 2019, the global market for biosimilar was USD 25 Billion and it is expected to reach USD 57 Billion by 2025. In the year 2006 the EMA approved Omnitrope (a biosimilar human growth hormone), EU’s first Biosimilar. Whereas in the US in 2015, nearly a decade later, the first Biosimilar which got approval was Zarxio, a prescription medication to reduce the risk of infection in certain cancer patient, by USFDA. Since then 26 Biosimilars are approved in the US whereas 15 of those are marketed till date, whereas for EU there are more than 50 approved and marketed Biosimilar since 2006.
• Cost saving in Developed Countries: In developed markets the expenditure of Biologics account for 24-30% of overall spend which is very expensive. Hence cost saving due to less expensive Biosimilars is one of the major driving factors for adoption in these developed regions. Therefore, the overall burden on insurance companies as well as on government budgets will be less due to adoption of more biosimilars.
• Expansion of Companies in emerging/low cost markets: Costing of a medicine in each country also depends on country’s dynamics such as spending power and accessibility to healthcare. In low cost regions such in South East Asia, Middle East, Africa, LATAM, etc. will see high adoption of biosimilars due to cost advantage.
• Patent expiry of major biologics: Many Biologics such as Humira, Avastin, Lucentis, Avonex, etc. are will lose patents in coming years. Therefore, companies are racing to get shares from Market Exclusivity as well as long terms sales.
• Rise in prevalence of non-communicable diseases
• Easy access to all distribution channels: Supply chain of many Biologics was very stringent and only specialty/specific sales channels were allowed. Whereas in case of Biosimilars there will be many sales channels and different types of companies in supply chain will get their pie of business.
• US FDA’s new guidelines on Biosimilar interchangeability: In recent policy adoption by FDA, it has mentioned that biosimilar can be substituted for reference biologic therapies w/o the intervention or sign-off of the prescribing healthcare provider.
• EU’s price and incentive policies: EU countries have adopted many pricing and incentive policies for increase in prescription & adoption of biosimilars such as subsequent reduction in price of innovator post arrival of biosimilars, incentives, reimbursement, and national policies.
• Geography: Asia Pacific is a very lucrative market for Biosimilars since it holds almost 1/3rd of overall market with growth rate of 20-30% PA. Affordability, Increase in Chronic Diseases, Push for local manufacturing by local governments, etc. are some of the reasons why this region is seeing huge increase in Biosimilars market. EU approved its first Biosimilar in 2006 whereas first approval came in US in 2015. Both regions are fast increasing in use of Biosimilars so as to reduce huge bills/expenditures by respective governments.
• Therapy: There are many potential candidates currently going through Phase III clinical trials in therapies such as Oncology, Immunology, Haematological Disorders, Metabolic Disorders, etc.
• Blockbuster Biologics: Biologics such as Herceptin, Avastin, Lucentis, Avonex, etc. are losing patents in different regions in very near future.
Many companies in APAC are exploring increase in approvals and exports to EU and US. Some recent updates include the following:
Companies covered in this section include Amgen Inc., Roche, Sandoz International, Dr. Reddy’s Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Biocon, Pfizer Inc. Samsung Bioepis, and Mylan N.V.
Biosimilars Market can be segmented into the following:
• Epoetin [EPO]
• Recombinant Human Growth Hormone (rhGH)
• Anti-Tumor Necrosis Factor [Anti-TNF]
• Granulocyte colony Stimulating Factor [G-CSF]
• Monoclonal Antibodies
• Blood Disorder
• Growth Hormone Disorder
• Chronic Disorder
Africa and Middle East
• Saudi Arabia
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