Regulatory News Roundup

Below are some recent regulatory developments in the biologics space.

  • As we previously reported, USP has been considering a revision to the naming conventions for the titles of biologics product monographs. Following comments from FDA, USP announced that it would not make any changes absent stakeholder consensus.  Last month, USP announced that it is deferring revision of its practices regarding the nomenclature for biologics.  USP said that it “will not move forward the portion of the General Notices proposal that addresses biological product nomenclature until USP has further engagement to better understand the implications of the General Notices proposal.”  USP also sent a letter to FDA regarding its decision.
  • On May 4, FDA announced it is establishing a public docket to assist in the development of a new policy/guidance document regarding drug-drug interactions (DDIs) for therapeutic proteins. According to the announcement, two previous draft guidance documents, published in October of 2017, do not address DDIs with respect to therapeutic proteins. Therefore, FDA is inviting those interested to provide information and comments on the DDIs of therapeutic proteins. Specific topics on which FDA is particularly interested, as well as how to provide this information, are included in the announcement.
  • On May 11, Dr. Sarfaraz K. Niazi, Adjunct Professor of Biopharmaceutical Sciences at The University of Illinois College of Pharmacy, filed a Citizen Petition which provides recommendations to FDA intended to hasten and streamline the biosimilar approval process. Specifically, Dr. Niazi proposes five broad actions:

(1) Modifying the current requirement of conducting bridging studies between a US-licensed product and non-US approved comparator to establish biosimilarity.
(2) Presenting clear and scientific views that biosimilars have “no clinically meaningful difference” from the reference product to prescribers.
(3) Encouraging the use of in vitro immunogenicity testing to reduce exposure of test subjects.
(4) Revising specific statistical methodologies used to establish analytical similarity.
(5) Reconsider protocols and statistical methods used to determine PK/PD similarity to make studies more cost effective and clinically relevant.

The Citizens Petition has been docketed as FDA-2018-P-1876 and comments from interested parties are due by Nov. 7, 2018.

  • On May 17, FDA announced that is has received numerous inquiries from generic pharmaceutical companies indicating that they would like to develop generic versions of marketed drugs, but have been unable to obtain necessary samples of the reference labeled drug (RLD). The inability of generic company to access RLD samples typically occurs when brand products are subject to limited distribution in connection with a Risk Evaluation and Mitigation Strategy (REMS), an FDA program implemented to ensure that a specific drug’s benefits outweigh its risks. According to FDA, “brand drug sponsors may use these limited distribution arrangements, whether or not they are REMS-related, as a basis for blocking potential generic applicants from accessing the samples they need.”

To address this issue, FDA published a list of RLDs and RLD sponsor companies for which FDA has received an inquiry regarding the inability of generic companies to obtain RLD samples. In accordance with FDA’s Drug Competition Action Plan (DACP), FDA stated that it is “committed – among other things – to addressing and improving transparency about this and other gaming tactics that delay the generic competition Congress intended.”