Biological pharmaceuticals are therapeutic drugs made from human or animal materials rather than chemicals, often indicated for immune system-related deficiencies. These drugs are made of large molecules and can have a direct effect on cellular function. There has been little room for advancement of these types of pharmaceuticals -- especially in a cheaper, generic form -- due to a lack of regulatory guidance from the Food and Drug Administration (FDA). Biologics are among the most expensive drugs on the market, so having a generic alternative (biosimilar protein product) will certainly make consumers happy at the pharmacy counter.

The FDA released new biosimilar guidance documents in early February. According to the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, “When it comes to getting new biosimilar products on the market, the FDA has taken an innovative approach to supporting their development at every step of the process.”

The new guidance documents from the FDA are linked below, and commenting from the public is requested before the guidance becomes official. The draft guidance documents outline a new approval pathway for enzyme and antibody products. These products are considerably more complex than small-molecule drugs in terms of physical and chemical properties. As a result, the evaluation and approval process for generic biological products will likely take longer and be more complicated than any other type of generic drug product.

Draft guidelines for biosimilars:

The basis of approval for a generic biological product is heavily based on a comparison of the generic version to the branded ‘reference’ version already on the market. The drug manufacturer must provide evidence that the molecular structure of the generic is biologically similar (or biosimilar) to the reference molecule. Officials are currently evaluating the extent of testing required, which may include clinical trials in humans, to determine the safety of the generic drug product. Unintended immune system responses have been expressed as a concern.

The historically now-famous health care bill that passed through Congress in March 2010 included a handful of notes about biosimilars and companies who produce biologics. According to the bill, these companies will be granted 12 years of exclusive market access before other drug manufacturers can produce biosimilar generics. The passing of this bill prompted many producers of biological products to pressure the FDA for more guidance on biosimilars. Finally, here in 2012, we have three generalized guidance documents in circulation.

Companies looking to produce generic biologics may have been holding off development because of a lack of clear guidance from the regulatory authorities. The FDA is eager to get biosimilars through the regulatory pipeline as fast as possible to drive down the costs of these expensive prescription drugs. The approach is an innovative move for the FDA. If deemed necessary, additional testing for safety, efficacy or chemical analysis may clog up the pipeline and result in additional costs for the drug manufacturer. With additional regulation in place for generics, the FDA will likely regulate most brand-name biological products as well.