A biologics is a product derived from living organisms or contains components of living organisms. Some of the widely used biologic drugs include adalimumab (Humira), abatacept (Orencia), certolizumab pegol (Cimzia), anakinra (Kineret), and etanercept (Enbrel).
Biological Medical Product
As the name suggests, a biosimilar drug is a biologic medical product that is highly similar to another already approved biological medicine. Amjevita (adalimumab-atto) is the first biosimilar approved for the blockbuster Humira (adalimumab) for the treatment of rheumatoid arthritis and psoriasis.
Currently, the use of biosimilars and biologics is limited to a handful of diseases and in a few economies. The upcoming patent expires of several blockbuster drugs are expected to facilitate remarkable and sustained growth of the biosimilars pipeline. However, there are several challenges in the development of biologics and biosimilars. The regulatory pathway is one of the major hurdles in the success of biosimilars and biologics. The development of generic products of small molecules was the beginning of several pharmaceutical manufacturers in order to reduce the cost of the final products. These small-molecule generics were highly identical to branded drugs. Now, the focus of the manufacturers is on the development of biologics of large molecule therapies. There are several factors that have brought this shift such as low R&D expenditure and no requirement of initial R&D in clinical safety. The only expense in this regard is for efficacy testing of the final product.
Challenges in Biosimilars and Biologics.
However, the use of living organisms in biologics leads to several challenges in their packaging. Another major challenge is the nomenclature of biosimilars and biologics. Every country may have its individual biosimilar nomenclature system and some may follow regulatory guidelines that are consistent throughout a region. Such a scenario is a bottleneck for the successful commercialization of products. The logistics and availability of patients for clinical trials, especially in the case of R&D of biosimilars and biologics for orphan drugs, is another mountain to climb. Although the scenario is more feasible in developing nations where recruitment is comparatively easier, the same cannot be considered for developed nations.
Switching patients back and forth between reference products and biosimilars is the next big hurdle in the way of biosimilars and biologics. This is attributed to concerns regarding the safety of patients while migrating from a reference product to its biosimilar. With the aging population and the associated increase in the prevalence of chronic diseases, it is indispensable to focus on deploying robust strategies that focus on cost-effective production and commercialization of biologics and biosimilars. This can be achieved through continuous investment and favorable government regulations for the development and marketing of biologics and biosimilars.
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