GEROPHARM Shared its Expertise in Biosimilar Development at the World Biosimilar Congress USA 2020

Roman Dray, Director of Research & Development Centre, GEROPHARM, featured as speaker and moderator at the discussion on biosimilar marketing and further development at the high-profile international World Biosimilar Congress USA 2020 that took place in San Diego, USA on March 2 to 4.

The forum is annually attended by more than 700 participants and 350 renowned expert speakers from across the globe.

The session on biosimilars titled “Marketing and Sustainable Development” covered such topics as biosimilar development in Europe and future-defining factors for biosimilars in the US, as well as the issues of marketing of newly developed products and related challenges.

Of note, according to experts, even the US with the currently strongest regulation start following the global trends towards biosimilars, including easing the authorisation rules and, therefore, lowering market prices for medicinal products. It is worth noting that the US is largely guided by the European experience. Moreover, experts noted that other countries, including Russia, tending to take the EMA guidelines.

Experts discussed the very concept of generics and biosimilars. These products contribute to a fair distribution of public resources allocated for covering public needs for medicinal products.

Nevertheless, in the current situation, biosimilar manufacturers face a number of challenges. Firstly, there are evergreen patents. Secondly, nominally next-in-class products, so-called 2nd-generation medicinal products emerge in the market. It refers to a phenomenon where an originator develops a modified molecule without changing its effects and indications. It happens at the moment when the life of an originator product patent is about to expire. Some of such “new drugs” are in fact far from the best-in-class but merely next-in-class instead, with no breakthrough advantages. The emergence of such products thwarts the progress of the global pharmaceutical sector while biosimilars inspire innovative companies to develop new high-margin products.

Roman Dray, Director of Research & Development Centre, GEROPHARM, says, “Another issue is the people’s apprehension with biosimilar use. It is commonly believed that biosimilars are not sufficiently investigated and that it is impossible to accurately reproduce exactly same protein. This belief is based on the lack of understanding of the very concept of biosimilarity. It has to be admitted that some 10–15 years ago it was the true fact. At that time, even if one succeeded to make an identical peptide, there were no analytical methods good enough to prove its similarity. A lot has changed since then. There are new technologies, new bioreactors, culture media, sorbents for better culture and purification conditions. New bioanalytical methods have emerged. Biotechnologies advanced enough to reproduce a similar protein and to prove its similarity with bioanalytical methods. However, the public is still driven by prejudice of the impossibility to reproduce a similar protein.”