Are you a biosimilar/biologic product’s developer/manufacturer? Are you waiting for FDA’s latest stand on biosimilars or soon-to-be Biologics? Here it is. For the development of biosimilars and interchangeable biosimilars, on 11 December 2018, FDA released two new draft Q&A guidance documents under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The agency also proposed two other documents on the same topic and a rule intended to amend the definition of a biological product. The recent developments are to initiate transitioning some of the marketing applications for a subset of biological products (such as insulin and human growth hormone - which were earlier approved as drugs under section 505 of the FD&C Act) to be deemed to be biologics licenses. The latest guidance documents are also set to answer questions about the exclusivity factors when a drug transitions into a biologic product.

The focus of the new guidance is, however, on the transfer of few biologics from FDA’s orange book (which lists drug products based on their safety and effectiveness) to the purple book (which lists biological products, including biosimilar and interchangeable products).

The purpose of the latest guidance documents is to prevent the sponsors from gaining exclusivity and put a stop on biosimilar entry, and that the transitioned biologics do not receive any additional exclusivity. It also proposes to modify the definition of biological products by providing its interpretation to the terms “protein” and “chemically synthesized polypeptide”.


  1. The “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)” gives more information about the nature and type of the information to be provided by a sponsor as post-approval manufacturing change for a licensed biosimilar product.
  2. The agency also answered some new questions such as “May a sponsor seek approval, in a 351(k) application or a supplement to an approved 351(k) application, of a route of administration, a dosage form, or a strength that is not the same as that of the reference product?” and “May a sponsor seek approval, in a 351(k) application or a supplement to an approved 351(k) application, for a condition of use that has not previously been approved for the reference product?”
  3. The “Questions and Answers on Biosimilar Development and the BPCI Act” document clarifies concepts of bio-similarity or interchangeability and provisions related to the requirement of BLA submissions for a biological product and exclusivity.
  4. The “The ‘Deemed to be a License’ Provision of the BPCI Act Questions and Answers: Draft Guidance for Industry” and “Interpretation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009” defines transition period for the concerned biologics and states guidelines on how to identify products subject to the transition, statutory or Regulatory requirements for BLAs, and transitioning biologics from the Orange to the Purple Book.

With increased significance towards biosimilars and soon-to-be biologics, manufacturers are required to decode the guidance documents and understand the implications of the new rules and guidelines and their impact on the products. For successful market-entry, stay informed, and stay compliant. 


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