Biosimilar Developers Comment on Regulatory Delays

Multiple biosimilar developers recently released statements regarding potential regulatory delays facing their biosimilars or follow-on biologics.


As we previously reported, Biocon and Mylan are collaborating in the development of a follow-on product to Sanofi’s LANTUS (insulin glargine). On February 22, 2020, Biocon announced that the U.S. FDA had conducted yet another pre-approval inspection (PAI) of its insulin glargine manufacturing facility in Malaysia and issued a Form 483 with three observations that Biocon believes are “procedural in nature.” According to the FDA, “observations are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.” In a press release, Biocon stated that it “will respond to the FDA with an appropriate Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously” without “in any way impact[ing] the commercialization plans of insulin glargine in the US.” Biocon further noted that the FDA set a target action date for Mylan’s pending New Drug Application for this product in June 2020.

On a February 27 quarterly earnings call, Mylan expressed its “confiden[ce] in [Biocon’s] ability to fully address the observations” and reiterated that it did “not believe that the inspection in any way impacts our commercialization plans of insulin glargine in USA.” Mylan also indicated that it remained on track to submit an application to the FDA for a follow-on product to Novo Nordisk’s NOVOLOG (insulin aspart) in Q2 2020.


This past November, Coherus and Bioeq announced an agreement under which Coherus will exclusively market and distribute Bioeq’s FYB201, a proposed biosimilar of LUCENTIS (ranibizumab), in the United States. Bioeq is a joint venture between Polpharma Group and Strüngmann Group (Santo Holding), and holds rights to FYB201 through a partnership with Formycon. Bioeq submitted an aBLA for FYB201 to the FDA in December 2019.

Last month, however, Formycon announced that Bioeq “decided to withdraw its BLA application for the Lucentis® biosimilar candidate” in order to respond to a request for additional data from the FDA. Formycon explained that “the drug substance contract manufacturer has moved a piece of processing equipment to a different location within the same site after the production of the FYB201 drug substance qualification batches was completed” and, as “a result of the move, the FDA has requested additional manufacturing data for the equipment in its new location in the context of its review of the BLA application.” According to Formycon, the FDA’s requests “are not related to the quality of the drug substance or other product characteristics.” Formycon further indicated that it and Bioeq “believe that it will take approximately four months to generate this additional data to comply with the FDA’s request” and resubmit the application.

Coherus addressed this turn of events on its February 27 quarterly earnings call, stating that Coherus was “focused on supporting [its] partner to generate the additional manufacturing data as requested by FDA and expect to resubmit the application upon completion of these efforts and certain regulatory interactions.” Dennis Lanfear, Coherus’s CEO, confirmed that generating the new data was “four months’ worth of work,” but noted that Coherus could not yet provide guidance as to the actual timing for resubmitting the application beyond stating the company’s belief that it “will get that file resubmitted certainly within 2020, which should get it approved in 2021.”