COVID-19 pandemic impact biosimilars
The recent outbreak of the COVID-19 pandemic has rattled the population all over the world. It has also introduced new challenges in the pharmaceutical industry, including the manufacturers of biosimilars. As the pandemic continues, concerns are being raised about the availability of active pharmaceutical ingredient (API) required for drug manufacture. In response to this, the Food and drug administration (FDA) is continuously monitoring the supply chains and brought light to some ways the virus could impact the product pipelines. From the supply side, 13% of the generic API is based out of China. The crisis is highlighting the vulnerability and dependency of the international supply. India in specific is heavily dependent on China for 70% of its pharma production. It was announced earlier this month, that China will be blocking 26 APIs and finished pharma products from being exported (roughly around 10% of India’s pharmaceutical volume). India supplies the United States with 18% of its API volume. On the demand side, patients delay seeking the treatment, particularly less convenient administration like infusions, leading to lower patient volume ultimately overall demand.
Supply chain disruptions:
In February 2020, the FDA reported its first case of a drug shortage due to COVID-19 and stated that it was the result of a manufacturer affected by COVID-19 that produces an API. FDA is reaching out to inform manufacturers to provide notice anticipating dug supply disruptions. Major pharmaceutical manufacturers, like Mylan, Jhonson & Jhonson, and Teva Pharmaceuticals have informed that their supply chain is being monitored constantly and that is there won’t be any near term shortages, although this could change id COVID-19 persists. All the manufacturing information, supply back up plans, should be made available in real-time so that the hospitals and other healthcare sectors can be prepared to meet any sudden demand. One factor that may buffer the impacts of manufacturing is that some companies tend to hold long-term supplies of the product on hand- around 6-12 months. With respect to biologics and availability, manufacturers that don’t have a lot of competition may have more supply because their market for products is secure.
Disruptions in Manufacturing:
The FDA’s response to the pandemic continues to evolve. Currently, the Center for Drug Evaluation and Research has temporarily halted all non-essential travel and has postponed all advisory committee meetings. Most of the foreign inspections have also been postponed through April 2020. To compensate for the effects associated with postponing on-site drug inspections, FDA announced inspections will be intensified following importation. Postponing the inspection of a manufacturing facility will lead to longer timelines to approval. The heightening of the inspection post-pandemic may cause delays or even rejection of the foreign-produced product seeking importation.
While the manufacturing of the products is complicated due to the pandemic, a further concern is product delivery. The huge restriction in movements around the world makes distribution and shipping a problem. On average an API needs to be transported to another place for manufacturing into finished product or many other places for more production stages. Pill casings are also needed which need to be transported from another place. All these elements have to be brought together in a single place for assembling the finished product and then be moved by logistics companies, who, despite all this, have movement and worker restrictions placed upon them.
Delayed responses from regulatory authorities:
As borders close around the world to contain the spread of the virus, conducting clinical trials is close to impossible due to site closures, quarantine and travel limitations. Other considerations include if trial subjects or site professionals become infected with the virus. Companies providing clinical trial facilities to drug developers, including designing and executing trials, have acknowledged that the recent pandemic has affected them from sending their personnel to visit hospitals and other clinical trial sites in China and other affected areas of the world. While other facilities which can be performed remotely has minimized disruption, the risk for further disruption is possible as pandemic spreads. The government issued stay-at-home orders have made it all the more difficult to recruit people to participate in clinical trials. While health care operations and their employees are exempt from such government orders, it is still unclear whether clinical trial participants are similarly exempt.
While the effects of COVID-19 have been overwhelmingly negative, there could be one positive result of COVID-19, companies may start to spread their production across different markets and smaller companies, limiting future disruptions. While drug shortages due to COVID-19 are under control, if the pandemic continues then stockpiles, APIs and other chemicals required may decrease, resulting in shortages. A further added complication is distribution, particularly with population movement restrictions all around the world. It is also advisable or pharmaceutical to monitor the continuously evolving situation and aware of the clauses that may lead to a problem in the long term. The circumstance affecting the ability of the FDA and the manufacturers is still very fluid. At the end of the day, the priority for everyone is protecting their health and safety. Although currently the biosimilars and evolution of new treatments may stall, it is firmly believed that health and safety are at most priority for providers everywhere.