Biologics - What's in a Name?

The World Health Organization (WHO) Expert Committee on Biological Standardization will meet at the end of this month in Geneva and will consider, among other issues, whether generic biotech drugs can carry the same clinical name or nonproprietary name as the brand-name drugs. Biotech drugs - also known as biologics or biopharmaceuticals - are some of the most expensive products on the market and form part of the arsenal against HIV/AIDS, cancer, and diabetes.

The WHO has established Guidelines on the Use of International Nonproprietary Names (INN) for Pharmaceutical Products, The WHO Programme on INN released a Review in June this year, which noted that INNs have not been assigned to blood biologicals and immunoglobulins, but have been used for some fusion proteins, gene therapy products, and transgenics. Skin substitutes are considered outside the system and vaccines are also currently not included in the system. However, the Expert Committee on Biological Standardization has made recommendations resulting in the assigning of some names.

In a recent report in The Independent, Danny Fortson describes political pressure for large-scale production of generic biotechnology drugs as a "fresh financial threat" to the pharmaceutical industry. But many commentators are concerned that this perceived "threat" is really simply an anxiety over protecting de facto monopolies in biological medicines. Such political pressure in the US comes recently from a new US Bill, aiming to improve access to lower cost drugs in the important area of pharmaceutical development.

US politicians, Representative Henry Waxman (of the Hatch-Waxman Act, establishing a system for generic drug approval in the US), and Senators Charles E Schumer and Hilary Clinton, have introduced the new bill, known as the "Access to Life-Saving Medicines Act." The aim is to establish procedures to facilitate approval of generic versions of biotech drugs. The press release notes the absence of statutory procedures for biotech drugs, leading to the potential problem of indefinite monopoly pricing, despite the expiration of patent protection.

The Bill has been strongly supported by the Generic Pharmaceutical Association (GPhA), which has stated "Introducing competition into the biopharmaceutical field would also yield tremendous cost savings for consumers ... We applaud Rep. Waxman and Senator Schumer for their true leadership."

Meanwhile, industry associations have maintained their objections, arguing that complex biopharmaceuticals cannot be copied in ways similar to traditional medicines, and so the application of traditional approval routes will not be appropriate. For instance, the VFAbio (Biotechnology within the German Association of Research-Based Pharmaceutical Companies) has urged that "such generics cannot exist."

In January 2006 the European Medicines Agency (EMEA) adopted its first positive opinion for a biosimilar, when it declared Omnitrope (Novartis) to be comparable to Genotropin (Pfizer), for which market authorisation was granted by the Commission in April (Omnitrope was later approved by the Food and Drug Administration (FDA)). In April the EU finalised its policy and legal framework for biosimilars when the EMEA adopted guidelines on the approval process for similar biological medicines.

However, the consultation on the draft guidelines attracted similar arguments, with the European Association for Bioindustries (EuropaBio) in its submission arguing that the application of the term "comparability" (from traditional manufacturing processes) to the biotech medicinal product is inappropriate. Similarly, the submission of Emerging Biopharmaceutical Enterprises (EBE) (European Biopharmaceutical Enterprises) emphasised that "Because no two cells are exactly alike, each biological medicinal product is distinct and cannot be copied exactly by a different company," while the Biotechnology Industry Organization (BIO) noted in its comments that "in important respects all protein products are unique, that each must be treated as such, and that tests performed by an innovator to demonstrate quality, safety and efficacy of its own product may not be relevant to a claimed-similar product." But Greg Perry, Director General of the European Generic Medicines Association (EGA) stated at the Biosimilars conference in London, that "The current level of biological science and recently enacted pharmaceutical legislation in Europe mean that the next generation of affordable medicines is no longer a distant dream, but rather a soon to be realised reality."

The EGA will be holding the 5th Annual Symposium on Biosimilars, "Biosimilar Medicines: Off the Starting Blocks," in London, May 2007. More details will be available early next year.