COVID-19 Pandemic May Impact Biosimilars

The COVID-19 pandemic has introduced new challenges for the pharmaceutical industry, including makers of biosimilars.  In response, the FDA has asked pharmaceutical makers to closely monitor their supply chains and highlighted some of the ways the coronavirus could impact developmental pipelines.

While the risk of supply chain disruptions is uncertain, the FDA is “keenly aware that the outbreak will likely impact the medical product supply chain.”  The FDA announced one shortage of a human drug product due to manufacturing of an active pharmaceutical ingredient at a site affected by coronavirus.  Currently, there are no known shortages of biologic drugs as a result of the coronavirus.   The FDA asked drug makers to evaluate the impact of the COVID-19 pandemic on their supply chains and reiterated the notice requirements triggered by an anticipated shortage.

Some biologics and biosimilar makers have made statements to reassure the public.  For example, Lilly announced the impacts of the pandemic are not expected to be significant.  Lilly expects to maintain adequate supplies for the foreseeable future.  During Mylan’s Q4 2019 earnings call, Mylan’s CEO pointed to its limited exposure to China as one reason why they do not anticipate any near term impact from the coronavirus.  However, Rajiv Malik, President and Executive Director of Mylan, noted that “from a supply chain point of view, I think the whole industry is in one way or another way connected with China.”  While no drug shortages are expected in the very near future, Mr. Malik acknowledged, “if this situation persists and continues for another few months, there can be an impact.”

The FDA’s response to the pandemic continues to evolve.  Center for Drug Evaluation and Research (CDER) has cancelled all non-essential travel and postponed advisory committee meetings through April 16, 2020.  The FDA has also postponed most foreign inspections through April 2020.  To mitigate the risks associated with postponing on-site drug inspections at foreign facilities, the FDA announced it may intensify inspection efforts following importation.  Postponing inspection of a foreign manufacturing facility required as part of a pending biosimilar application could lead to longer timelines to approval.  Heightened inspections upon importation may cause delays to or rejection of foreign produced regulated products seeking importation.

The FDA recently highlighted another challenge brought on by the COVID-19 pandemic.  The FDA issued a guidance in view of expected difficulties in conducting clinical trials due to “quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19.”  Companies that provide clinical development services to drug developers, including designing and executing clinical trials, such as Syneos Health and PPD have acknowledged that the COVID-19 pandemic has impacted their ability to visit hospitals and other clinical trial sites in China and other impacted area to conduct monitoring visits.  While the ability to perform certain services remotely has helped to minimize disruption, the risk for further disruptions grows as the pandemic spreads.  Shelter-in-place or “stay-at-home” orders, such as the ones issued in California and New York, may make it more difficult to recruit clinical trial participants or conduct trials.  While health care operations and their employees are exempt from such orders, it is unclear whether clinical trial participants are similarly exempt.

The circumstances affecting the ability of the FDA and biosimilar makers to fully conduct business remains very fluid.  There is significant uncertainty as to the extent, speed, and duration of the COVID-19 pandemic.  This uncertainty is amplified as governments have needed to adjust their efforts to contain its spread.