On April 30, ASBM submitted comments to the European Medicines Agency’s (EMA’sCommittee for Medicinal Products for Human Use (CHMP) as part of a public consultation period on the Agency’s “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development”. The document expresses the EMA’s intent to streamline biosimilar development by reevaluating the role of clinical safety and efficacy data.  From ASBM’s comments:

We believe that clinical data, including comparative effectiveness studies
(CES), have played a critical role in building physician and patient
confidence in biosimilars and should continue to be required for complex
biosimilars such as monoclonal antibodies. CES are critical because they
provide direct evidence of how a biosimilar works in humans. They
demonstrate real, not merely theoretical safety and efficacy in a wide
variety of patients. CES also helps address individual patient variability.
Replacing the current, highly successful approval standards could
undermine this success, potentially causing physicians to be less accepting
of newer biosimilars approved under the lower standard, and instead
preferentially prescribe the reference product or earlier biosimilars
approved under the previous, more robust standards.

Similarly, the change may have unforeseen negative effects on patient
confidence in biosimilars. Knowing that a biosimilar has undergone
thorough clinical test-ing to demonstrate its safety and effectiveness can be
reassuring for patients, especially those switching from a well-established
biologic therapy. It is conceivable that a mass nocebo effect could be
produced across many patient populations by these regulatory changes,
stemming from patient uncertainty over reduced clinical testing
requirements and lowered approval standards driven by cost-cutting and
desire for speedier approval.

Read the concept paper here.

Read ASBM’s comments here.