The production of biosimilar drugs remains at a rapid pace, and represents not only an advantage for patients, but a remarkable profit opportunity for drug makers. And for patients, the approval of biosimilars may represent the only alternative of treatment due to the extremely high cost of many original biologic drugs.

That said, in comparison to both brand and generic small molecule drugs, biologic drugs involve a much more complex and lengthy manufacturing process. Generic small molecule drugs typically have a relatively simple chemical structure that can be reproduced or processed so that the chemical itself is identical. By contrast, the development of biosimilar drugs requires extensive characterization to demonstrate high similarity to the original molecule, which is a current regulatory requirement.

Yet, developing a biosimilar drug is much less costly than its reference (brand) biologic drug. Biosimilars are expected to take 8 to 10 years to develop at a cost between US$100M and $200M, compared with an estimated cost of $2.6B for developing a new biologic drug. In addition, biosimilars introduce competition into the healthcare system, as the number of treatment choices increases for a particular disease or condition.

To facilitate the approval of biosimilar drugs, the U.S. Congress enacted in 2009 the Biologics Price Competition and Innovation (BPCI) Act1 as an amendment to the Public Health Service (PHS) Act. This Act created a legal framework to allow an abbreviated approval pathway to offer the public greater access to safe and effective biologic drug products. Europe started the biosimilar drug legislation process earlier by issuing the first Directive 2001/83/EC in 2001.

By 2023, biosimilar competition in the biologics market is projected to be nearly three times larger than it is today. This will result in approximately $160 billion in lower spending over the next five years than it would have if biosimilars had not entered the market.2 Thus, the development of biosimilar drug products to treat multiple types of cancer and autoimmune diseases, among others, represents an appealing business opportunity for the pharmaceutical sector and a way to meet the growing demand for biotechnology drugs.

CATO SMS consulting group comprises a team of international regulatory experts able to collectively leverage their global experience developing biosimilar programs and mitigating risks to help ensure regulatory approval. Our group of experts include 1,200 dedicated professionals and 13 former Agency regulators and policy makers with direct experience in the most influential pharmaceutical Regulatory Agencies in the world. Our experts are familiar with the applicable regulations, guidelines, and recommended practices that can facilitate the approval of the new biosimilar drug products across various regulatory and scientific contexts.  

References

  1. Section 351(k)(2)(A)(i)(I)(aa) of the Public Health Service (PHS) Act
  2. The Global Use of Medicine in 2019 and Outlook to 2023. Forecasts and Areas to Watch Institute Report (January 29, 2019)

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