Tony Hagen is senior managing editor for The Center for Biosimilars®.
In light of the COVID-19 outbreak, the FDA has suspended foreign inspections of FDA-regulated manufacturing plants and products. Meanwhile, escalating foreign travel restrictions put a damper on growth of the biosimilars industry.
Seeking to protect its employees from COVID-19 and recognizing the encumbrance of foreign travel restrictions, the FDA has suspended foreign inspections of FDA-regulated products and manufacturers through April.
“Inspections outside the United States deemed mission-critical will still be considered on a case-by-case basis,” FDA Commissioner Stephen M. Hahn, MD, said in an agency statement. For the most part, the FDA is confident that it can do the job by remote, using alternative tools, he said.
Hahn acknowledged that the lockdown on foreign travel may affect the pace of reviews for drug applications.
Among the workaround tools the FDA has at its disposal are inspections at the border, denying entry of products deemed unsafe, weighing the compliance history of manufactuerers, collaborating with foreign regulators, and considering data “in advance of or in lieu of” on site inspections.
The FDA said it put these tools to work during the initial stages of the COVID-19 outbreak in China.
The State Department has issued a Level 4 travel advisory that prohibits foreign travel for US government employees. Travel restrictions related to COVID-19 began January 23, 2020, when China imposed a quarantine around Wuhan, the epicenter of the outbreak.
The restriction put a crimp in the plans of Republic of Korea company Celltrion to move forward with construction of a $514 million plant for the manufacture of biologics, including biosimilars, in Wuhan. Celltrion evacuated its employees and announced it would manage construction of the plant from afar until the outbreak resolves.
The latest country to announce travel restrictions is India, which announced its intention Wednesday to stop issuing most visas for travel until mid-April. The country said it would quarranting all incoming travellers, including Indian nationals, arriving from China, Italy, Iran, Republic of Korea, France, Spain, and Germany.
Like China, India also has significant designs on the biosimilar industry, which inevitably will be affected by the travel ban. The Indian biosimilar market was estimated at US $300 million in 2015, with domestic sales of $250 million and exports of biosimilars or other biologics of $51 million.1
The country was an early adopter of biosimilars and developed a guideline in 2012 for the pre- and postmarketing approval of similar biologics. Biosimilars approved and used in India mainly include vaccines, monoclonal antibodies, insulin, and recombinant proteins.
Travel bans imposed on the Wuhan district were successful in controlling the spread of COVID-19, but only slightly, according to a study published March 6, 2020 in the journal Science. The study demonstrated that by the imposition of the travel ban January 23, 2020, most Chinese cities had already received many infected travelers. “The travel quarantine of Wuhan delayed the overall epidemic progression by only 3 to 5 days in Mainland China,” the authors wrote.2
The investigators found that the lockdown was effective in delaying the international spread of the virus, but only by a few weeks. They said that travel restrictions must be paired with public health interventions and behavioral changes.