Revised US-FDA Regulations To Facilitate Biologics Drug Development

24 Dec, 2019

The US Food and Drug Administration (FDA) has revised its regulations to eliminate outdated biologics requirements, thus allowing drug manufacturers to employ new manufacturing technologies and testing capabilities. Standard preparations (standard solutions containing a precisely known concentration of an element), which help to ensure safety, purity and potency of biologics can now be obtained from sources other than the FDA’s Center for Biologics Evaluation and Research (CBER), or can be developed internally by the biologics license applicant. The FDA has also removed a rule (Section 610.21 of FDA code) which specifies minimal potency limits to be met for certain antibodies and antigens. In addition, the FDA is also updating regulations (Section 610.53 of FDA code) regarding storage periods and storage conditions for biologics. These amendments in regulations are expected to increase regulatory flexibility by allowing the pharmaceutical industry and the FDA to incorporate current scientific technologies in the manufacture of licensed biological products.

Technological advances will be an important continued driver of market growth for biologics in the forecast period. The global biologics market, valued at around $266 billion in 2019, is expected to grow to $319 billion by 2021, at an annual growth rate of more than 9.5%. An area of particular development is likely to be physiology simulation modeling. Markets such as biologics will benefit from the greater efficiencies offered by developments in this area. For example, Eli Lilly and Pfizer have adopted Amazon’s Elastic Compute Cloud (EC2) platform to conduct simulation models in early drug discovery that have been operational within hours, whereas traditional models would have taken weeks to conduct simulations. The Open Innovation Drug Discovery program is another initiative by Lilly to enhance the research and development of biologics.

The biologics drugs market is highly regulated with authorities and regulatory bodies regulating the development and marketing of biologics in each country. The US Biologics Price Competition and Innovation Act, or Biosimilars Act, provides innovator biologics manufacturers with market exclusivity and delays market entry for manufacturers of generic biologics. The Biosimilars Act will thereby encourage the development of new innovative biologics. In the European Union, the European Medicines Agency (EMA) is responsible for setting guidelines for the regulation of biologics and biosimilars. It also assures that manufacturers conform to these regulations and once in the market, these biological drugs are monitored through pharmacovigilance activities. This ensures the safety of these drugs in the European market.

In Asia Pacific, the major regulatory bodies in the biologics market are Therapeutic Goods Administration (TGA), China Food and Drug Administration (CFDA), Central Drugs Standard Control Organization (CDSCO), and Pharmaceuticals and Medical Devices Agency (PMDA).