MHRA is one of the leading Health Authorities. The new MHRA guideline is straightforward about what has been discussed for a long time. The open question remains when other regulators (EMA, HC, FDA ...) will adopt a similar philosophy on biosimilars development. This approach opens up new horizons for smaller pharmaceutical companies, increases competition on the market, and, as a result, will also increase the availability of biosimilar drugs.
Key conclusions related to the clinical part:
“Confirmatory efficacy trial. Although each biosimilar development needs to be evaluated on a case by case basis, it is considered that, in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach. Therefore, a well-argued justification for the absence of an efficacy trial should be appended to CTD Module 1 of the submitted application. (…).”“(...) a justification should be provided that comparable efficacy can be derived from comparable binding properties and functional characteristics. Any observed differences must be justified as not clinically relevant, based on specific experiments and available literature.”“Justification for comparability of the biosimilar is informed by clinical experience and quality attributes of the RP”“The quality attributes, including drug product characteristics (protein aggregates, impurities) and formulation of the biosimilar candidate should form the basis for justification that safety and immunogenicity are comparable to those of the RP”"Once a biosimilar candidate has been shown to be highly similar to the RP in terms of analytical characteristics and functional properties related to the MOA of the RP (...), all the indications granted to the RP can be claimed by the biosimilar candidate without further justification, provided they are not protected by market exclusivity or patent."Ref:
https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products
Waiting for your thoughts and comments ....
