With increasing regulatory clarity and high revenue potential, interest in biosimilars increases
With increasing regulatory clarity and the expiries of key patents covering innovator biologics, the development of biosimilars for a range of recombinant protein classes is becoming increasingly attractive. Although many companies are targeting the market, 12 companies dominate. These include established generics companies, leading biosimilars developers, plus emerging biosimilar developers.
Well-established generics companies such as Sandoz and Teva have led the drive into the biosimilars market, by launching across a range of emerging and Western markets in a small number of well-characterized and relatively simple recombinant protein classes with significant market potential.
Although established generics companies have so far dominated the biosimilars landscape, emerging biosimilar developers have the greatest number of disclosed pipeline biosimilar programs, which are set to broaden the range of biosimilars being developed in terms of protein class, drug delivery and formulation.
There has been significant licensing and M&A deal activity among the top-12 biosimilar companies, enabling them to build a stronger product portfolio and gain greater access to capabilities that are key to competing in this market, such as drug delivery (primarily advanced injection technology) and drug formulation (mainly pegylation) technologies.
In collaboration with Regulanet network of regulatory affairs consultants throughout Europe and USA, we keep
daily contacts and communication with National Agencies for Medicines
and Medical Devices. Beside regulatory we also maintain understanding of the business, scientific and technical background of products.
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