Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 73

Biosimilar players are presented with an opportunity to take sales from 15 of the top 20 biologics in most developed countries by 2020, a market value greater than US$80 billion (DRG, Company & Drugs, April 2016). Investment barriers have meant that these players will face fewer competitors relative to the small molecule generic market. However, the competition that is present has formidable resources to draw from. Leading players have been gaining experience taking biosimilars through regulatory approval. Their legal teams/partners have been setting precedents while clearing patents to prevent at‐risk launch. This experience will be invaluable when preparing launches for the many biosimilar targets that will be presently moving forward. Some players such as Novartis/Sandoz, Merck & Co, and Amgen will be playing in both the originator/innovator and the biosimilar space. These hybrid players can leverage their expertise in biologic development and manufacturing to generate synergies. They also have the financial capacity to invest heavily in this space. However, they will face a certain degree of conflict of interest.

Biosimilar players can also bring bio‐betters to market. Today's off‐patent originator molecules were engineered over 15 years ago. Since then, scientific advancements have enabled biosimilar developers to improve the molecule significantly. Novel screening methods have assisted in the detection and replacement of immunogenic parts of the protein; iterative binding assays have improved specificity and binding strength; better understanding of structure/solution stability and stress tests have improved the temperature stability and shelf life. However, these improvements with respect to biosimilars are limited by the regulatory requirement to keep the molecule like the originator, this is to enable simple switching and to avoid dosage confusion.

The challenge is that there is currently no dedicated FDA or EMA regulatory guidance for bio‐betters. Approval through a novel medicine's pathway would require the developer to invest in clinical trials at a scale like creating a new biologic product. If the improvements on the molecule are not transformative, and payers do not see a profound therapeutic value, the return will not be high enough to justify investment. In the longer term, the development of an abbreviated bio‐better regulatory pathway remains a possibility. As the biosimilar market becomes more competitive, players looking for product differentiation may explore this bio‐better route.¹³