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Biosimilars and Biologics

Opportunities for blockbuster growth

Prasanthi Sadhu, Editor, Pharma Focus Asia

The COVID-19 pandemic has impacted many industries alike and the impact on biosimilars market was no different. Lockdowns causing short fall of resources, delays in clinical trials, slowdown in FDA approvals of non-COVID drugs have influenced the R&D activities and the biosimilars pipeline. This has been a great challenge to the pharmaceutical companies focused on biosimilar development. However, as companies began to resume their operations at full scale, development of biosimilars appears to be on track.

Several blockbuster biological drugs have expired, and many are inching towards their patent expiry in the next year or two, highlighting a huge opportunity for biosimilar manufacturers. Factors like rising prevalence of chronic diseases, patent extensions, cost-saving initiatives by governments and third-party payers have also driven the growth of biosimilars. With biosimilars showing equal efficacy and safety in comparison with original drugs at much lower costs, several countries are looking to make the switch to biosimilars by enacting favourable regulations.

Since the first biosimilar of a monoclonal antibody for treating autoimmune diseases such as ankylosing spondylitis, rheumatoid arthritis gained regulatory approval from the European Medicines Agency in 2013, biosimilars have come a long way to offering clinical outcomes equivalent to the original drugs. Be it chronic, immunological diseases or rare diseases, biosimilars have in a way brought a rapid change in the treatment of diseases. Recent trends indicate clinicians actively suggesting the use of biosimilars for treating several diseases (including…). From a cost savings and market share standpoint, the more recent biosimilars are indeed known to faring well in comparison to their predecessors. According to McKinsey’s biosimilars market model, biosimilars have shown a remarkable growth from 2015 to 2020 and could see a double-digit growth to touch US$30 billion by 2025 and US$60 billion by 2030.

North America, with a large number of key players in the market, could witness a significant CAGR over the forecast period. Leading biosimilar companies like Pfizer Inc., Mylan NV, Amgen Inc., and Coherus Biosciences Inc., along with others in developing countries, are focussing on innovations for novel biosimilar drug developments, especially in the treatment of the present coronavirus pandemic. With the highest geriatric populations, Europe is contributing its share in the biosimilars market followed by the Asia-Pacific region.

As the world continues to fight the outburst of several diseases, cost effectiveness and clinical efficacy offer bright promise for biosimilars. However, educating and communicating the benefits of biosimilars on a large scale is essential for a widespread awareness for the health systems to become more sustainable.

This issue presents the article by Ayaaz Hussain Khan, Managing Director, Global Head-Generics, Navitas Life Sciences that details key trends that will drive growth in the biosimilar and biologics market across the globe. I believe you will find the articles very insightful.

--Issue 44--

Author Bio

Prasanthi Sadhu

Prasanthi Sadhu, Editor, Pharma Focus Asia

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