Game Changer – FDA Biosimilar Action Plan

The FDA has announced the creation of Biosimilar Action Plan. The aim of this plan is to clarify and increase efficiencies in the Biosimilar Approval Process. It will also look at some legal considerations to curve practices from current innovator which the FDA sees as anti-competitive behaviors and gaming the current system. The biosimilar action plan contemplates many changes that will enable biosimilar companies to accelerate their existing or stalled plans. The FDA is going one step further by partnering with other government agencies to also increase access after approval. The latter may proof to be the most challenging as the innovator companies continue to build patent moats around their products.

The following is summary of what we see as the most impactful elements of this recently released plan by the FDA. For a full detail read please follow link is provided https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm613761.pdf


(1)   Reduction in size of clinical trials

(2)   Full revamp of similarity assessment guidelines reducing number of lot requirements

(3)   Increase availability of data from sponsor

(4)   Simultaneous US and EU approval and maybe even Japan

(5)   Elimination of practices from Innovators reducing number of lots and quantity of samples for clinical studies

(6)   Removal of distributor and innovator relationship where lots are not made available for critical studies

(7)   Large companies conducting large and cost prohibitive trials to reduce smaller companies ability to compete and bring product to market.

(8) Clarity on analytical similarity with the publication of the CQA index


(1)   Establishment of new office Therapeutic Biologics and Biosimilars Staff (TBBS)

(2)   Creation of Biosimilar Product Development (BPD)

(3)   351k submission templates

(4)   Transitioning TBBS to Office of Therapeutic Biologics and Biosimilars (OTBB)

(5)   Ability to use Non-US comparitor for clinical and similarity studies

(6)   Detail review of published guidances using public hearings and comments

The proposed changes can be game changers for current and new biosimilar developers. The biosimilar action plan has the potential to accelerate the biosimilar development. Simultaneously, reducing billions of dollars from healthcare cost. Most importantly provide access to people who can not afford it and reduction of personal bankruptcy which results from the super expensive life saving medicines.

We at Biosciencescorp look forward to the execution plan that will add teeth to the proposed outline published by the agency.

As always if you have any comments please do not hesitate to contact us or submit your comments via linked. Please e-mail me at Robert.Salcedo@biosciencescorp.com. We look forward to your feedback.