The Dolcera Blog

Follow-on Biologics or Biosimilars are generic versions of Biopharmaceutical products. The vastly increased complexity of Biosimilars as compared to common traditional small-molecule drugs and the complex means for the production of Biologics (Molecular cloning, fermentation and purification processes etc.) makes it all the more difficult to ensure that an imitator product is biologically and functionally equivalent to the original. Though the generic version uses the same mechanism of action and performs essentially the same role as the original version, it is difficult to create an exactly similar copy of the original version due to complex manufacturing processes and hence the name “Follow-on Biologics”.

With many Biopharmaceutical product patents nearing expiry in the US, the government has realized the importance of regulation at the level of approval to ensure safety and efficacy of Biosimilar products.

The Hatch–Waxman Act, 1984 was the conception point for regulation of the use of follow-on biopharmaceuticals. It provided incentives to generic manufacturers by lowering the cost of approval of Biosimilars as they have to demonstrate bioequivalence but not repeat the human trials for proving efficacy and safety of the product. The act also established minimum periods of market exclusivity for brand-name products.

The European Union has established a special approval procedure which is more stringent than required for chemical generics and also requires much more comprehensive information.

Other issue involving Follow-on biologics is the period of market exclusivity for brand-name biopharmaceuticals. A period of market exclusivity would provide the incentive for investment in research and development for newer Biopharmaceuticals but also hinder the price competition from Biosimilars which lower the cost of medicine and make it affordable to the general public.

While the debate is still on, White House believes a 7-year data exclusivity period “strikes the appropriate balance between innovation and competition.” Previously, PO Board adopted a resolution in September 2008 supporting legislation that “promotes continued innovation by providing at least 14 years of data exclusivity for an innovator’s biological product with additional periods of exclusivity available for new indications and/or for approval for use in the pediatric population. We can hope that to ensure safety and efficacy of Biosimilar products US Govt. will come up with a solution appeasing both companies and consumers.

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Priyanka Goyal
Knowledge Scientist
Dolcera

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