A summary drawn from the article:
Biosimilars: The Road Ahead in Rheumatology
Quick Read Summary
There's going to be numerous biosimilars for infliximab, etanercept, adalimumab. Presently, there are about 11 adalimumab biosimilars under development, seven or eight infliximab biosimilars under development, multiple etanercepts under development.
Many health jurisdictions are keen to promote biosimilars as they are expected to be 30% cheaper than the original biologic. Pressure may be applied to users to switch to the cheaper product. To date, switching seems to present few issues of concern.
The Dragon Claw position is that users should have the right to return to the original biologic should the biosimilar provide inadequate cover.
- Biosimilars are proteins that are very closely related to biologics
- Biosimilars are going through regulatory approval process for use in Rheumatoid Arthritis and Lupus. The regulatory agencies have set a pathway for the approval of biosimilars.
- In a trial looking at the differences between the biologic adalimumab and its biosimilar, responses were determined to be no different, equivalent, between the original biologic and the biosimilar as determined by the regulatory agency's requirements.
- Other clinical outcomes looking at changes in DAS scores, swollen and tender joint counts, acute phase reactants, were all equivalent.
- Safety outcomes were numerically identical-- gastrointestinal upset, headache, and respiratory tract infections.
- In the long-term at the end of 70 weeks the change in DAS scores, the disease activity index were the same.
- Looking at safety issues there was no increase in the risk of moderate or serious adverse events.
- Biologic therapies can be associated with a higher risk of infection such as upper respiratory tract infections, lower respiratory tract infections – pneumonia or sepsis. No differences were observed between biosimilars and biologics. The same was true for cardiovascular outcomes.
- Concerns about switching from a biologic to a biosimilar appear to be unfounded but few jurisdictions have published guidelines for switching.