Biosimilars and Impact of Covid-19 Pandemic That Led To Manufacturing Disruptions and Discontinuations
Biosimilars, also known as biologic products, are currently the
fastest-growing category of medical products in the United States, with sales
estimated at more than $40 billion dollars annually. When prescribed by
doctors, these products may provide more effective treatment options for
patients suffering from a chronic disease or condition.
In late August, the FDA held a forum on biosimilars. The topic was
"biosimilar medications - what are they, how do they work, and are they
safe and effective." Representatives from the FDA, pharmaceutical companies,
and biotechnology organizations attended the forum. The forum included
individuals who are leading the charge to register biosimilar products for
clinical trials. According to the FDA, the agency will begin accepting
applications for biologic drugs in late fall of 2020. In Japan, various
manufacturers are focused on developing pipelines that contain biosimilar
candidates aimed at treating various therapeutic conditions for patients in
Japan. For instance, in December 2020, Alvotech and Japanese pharmaceutical
company Fuji Pharma agreed on an extension on their exclusive strategic
partnership for the commercialization of four biosimilar medicines in Japan.
Biologic
drugs are designed to function differently from their counterparts. Instead
of using the same structure and composition as an active ingredient, biosimilar
medications are manufactured to specifically elicit a response from the body's
immune system. For this reason, these drugs must meet additional clinical
requirements that are different from those required of traditional,
FDA-approved products. In addition to meeting additional FDA requirements,
biologic drugs must also comply with other federal and state laws.
Although the FDA has recognized the importance of meeting the
standards required by the European Food Safety Commission (EFSA), there are
differences between the two regulatory bodies. For example, unlike the U.S Food
and Drug Administration, the EFSA does not require that manufacturers conduct
clinical trials. Manufacturers are not required to create a labeling that can
stand up to scrutiny by clinical trial experts. And although the FDA requires
drug companies to conduct post-marketing surveillance, the EFSA does not
require manufacturers to notify the FDA when safety concerns are identified. In
addition, unlike the US Food and Drug Administration, which have authority over
cosmetics-related clinical studies, the EFSA is limited to regulating
cosmetics-related safety data only.
Because biologics have become such a hot topic recently, there are
several new product lines on the market. One of the most exciting recent
developments in the area of biologics is designer drug products, or DSLs, which
are specifically tailored to meet the unique needs of each patient. Designer
drugs are engineered to provide a greater degree of response to the treatment
regimen by utilizing the strengths and the synergistic properties of previously
developed drugs. The combination of an optimized drug and a DSL yields a more
effective outcome for patients with chronic diseases.
Currently, there are no approved biologic product applications
currently in development for treating any of the following conditions: Crohn's
disease, hepatitis, Lou Gehrig's disease, Orleritis, Rheumatoid arthritis,
Sepsis, Systemic Lupus erythematosus, or autoimmune thyroid disease. However,
the sectors of the pharmaceutical and biotechnology industries are constantly
working toward developing new, and improved, Biosimilar
products for medical indications currently unmet. For more information
regarding biosimilar products, including safety data, see the FDA site on
biosimilar (bio) similar drugs. Although the benefits of these medications have
not been established, they may prove to be a valuable treatment option in the
future. The pharmaceutical sector has witnessed a mixed impact of the Covid-19
pandemic. A major concern is the consistent production of biosimilars. In April
2020, the U.S. FDA asked manufacturers to notify the agency about manufacturing
disruptions and discontinuations regarding biologics, biosimilar drugs, and
other pharmaceutical products. The agency has asked manufacturers to keep it
posted on the situation every 2 weeks until the issues have been resolved and
has also identified 20 drugs whose active pharmaceutical ingredients (APIs) are
sourced from China.
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