By Kurt R. Karst –
The Alliance for Safe Biologic Medicines (“ASBM”), a self-described “organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion,” urges FDA in a new paper to adopt unique non-proprietary names for all biological products licensed under the Public Health Service Act (“PHS Act”), and in particular biosimilar versions of reference products (even those that are interchangeable). The paper, titled “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar Therapeutics?,” appeared in the latest edition of the Food and Drug Law Institute’s “Food and Drug Policy Forum,” and is the latest effort by ASBM and its members to advocate for unique biosimilar naming. Over the past few months, ASBM and several member organizations have sent letters to FDA (see here) saying that it is essential that each biosimilar licensed under PHS Act § 351(k) have a unique name in order for patients and physicians to easily distinguish between medicines and to track and trace adverse events for such products.
The “naming issue” has been around since well before the May 23, 2010 enactment of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created the biosimilars pathway in the U.S. For example, in an October 2006 Policy Position on Naming of Biotechnology-Derived Therapeutic Proteins submitted to the World Health Organization (“WHO”), several organizations, including PhRMA and BIO, recommended the assignment of distinct International Nonproprietary Names (“INNs”) to each biotechnology-derived therapeutic protein produced by different manufacturers in order to “accommodate the acknowledged complexity of protein medicinal products and best meet the WHO Objectives for INNs to facilitate safe prescription and dispensing of medicines and preserve patient safety.” (An INN is the official generic name assigned to a pharmaceutical’s active ingredient by the WHO and applies to each product globally.) Just a month before, FDA had commented (see here, page 9) to the WHO that “INNs for biologicals should not be used to imply product interchangeability in the absence of credible scientific evidence. Likewise, however, INNs should not be used to differentiate biological products with the same active ingredient(s) when credible scientific data demonstrate that no pharmacologically relevant differences exist.”
The BPCIA, as enacted, does not specifically address biosimilar product naming. Although previous biosimilar legislation did address the issue, such as Representative Henry Waxman’s (D-CA) Access to Life-Saving Medicine Act (H.R. 1038) and Senator Judd Gregg’s (R-NH) Affordable Biologics for Consumers Act (S. 1505) (both from 2007), it was ultimately decided that naming provisions should not be included in the final biosimilars bill. Given that “hole,” and an intensifying interest in a U.S. biosimilars market, the “naming issue” has taken on a life of its own. Indeed, it was a much discussed issue at FDA’s November 2010 public hearing on the Agency’s implementation of the BPCIA.
ASBM makes the point in its FDLI Policy Forum paper that:
The need for clear, defined naming considerations and a system to implement an effective tracking and tracing of all biologics – not just biosimilars – stems from the potential of these products to be unexpectedly altered by the manufacturing process, handling, etc., in a manner that could cause unintended harm to patients. Whether the products that FDA approves will have the same name or a different name than the originator biologic will determine how well products can be traced back to a patient who has an adverse reaction.
With this backdrop, ASBM outlines what it says are key components that FDA must address in the biologics naming space, and makes four recommendations:
1. All biologics should receive distinct non-proprietary names;
2. The United States Pharmacopeia should work with FDA to adapt the product monograph system to accommodate the unique attributes of structurally-related, but distinct, biologic medicines;
3. The non-proprietary name of a reference product and product/s biosimilar to it should have a common, shared root but have distinct and differentiating suffixes; and
4. Products designated interchangeable should have a distinct name from the reference product for which they are considered interchangeable to facilitate accurate attribution of adverse events.
On the other side of the fence, the Generic Pharmaceutical Association (“GPhA”) has taken the position that “[c]onsistency, patient safety and sound scientific principles necessitate biosimilars having the same INN as their specific reference product,” and that “[t]here is no evidence that a unique INN will improve the effectiveness of pharmacoviligance.” Moreover, says GPhA, the BPCIA does not require different names for biosimilars and their reference product counterparts, and requiring different names for interchangeable products effectively make such a determination meaningless.