It is well known that pharma companies are ready to chip on shoulders with rival companies in any regulatory or marketing disputes. Recently pfizer has took a dig against Amgen, Johnson & Johnson and Genentech for allegedly distribiting false and misleading information about use of biosimilars in the U.S. Pfizer filed citizen petition and requested FDA that they should issue guidance to ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics.
Pfizer highlighted that recent survey conducted by the Decision Research Group, six months following the launch of rituximab biosimilars, the majority of surveyed oncologists in Germany responded that they prescribed at least one of the rituximab biosimilars to their patients and were satisfied with their use. Similarly, when asked about the adoption of trastuzumab biosimilars, surveyed European oncologists reported that they anticipate prescribing the biosimilars to the majority of patients eligible for intravenous trastuzumab therapy. Furthermore, although there is variability in the EU in the penetration of biosimilars by country and therapeutic area, an analysis by QuintilesIMS (now IQVIA) found that, across therapeutic areas, the competition provided by biosimilars has contributed to increased patient access. This increased patient access extends not only to biosimilars, but also to their reference products and other products in the same therapeutic class.
Pfizer noted that Genentech’s “Examine Biosimilars” website explains that “FDA requires a biosimilar to be highly similar, but not identical to the [reference product]”, but fails to state that an approved biosimilar must have no clinically meaningful differences from the reference product.
The tweet by Amgen Biosimilars also contravenes the statutory standard that a biosimilar is highly similar to and has no clinically meaningful differences from the reference product: “Biologics or biosimilars? It’s not just apples to apples. While biosimilars may be highly similar to their biologic reference products, there’s still a chance that patients may react differently.
Pfizer argues the statements in patient brochure entitled, Finely Tuned – Your Treatment, Your Choice, Janssen Biotech Inc., maker of REMICADE® (infliximab), fails to mention that an approved biosimilar has no clinically meaningful differences from the reference product.31 Janssen’s materials also caution, “you may be asked to switch to a biosimilar that works in a similar way to REMICADE.” The BPCIA explicitly states that a biosimilar is highly similar to the reference product but has the same mechanism of action, meaning that a biosimilar works in the same way as the reference product. Janssen’s materials confuse this distinction by stating that infliximab biosimilars work in a “similar” way to REMICADE.
Pfizer also flags, Amgen's YouTube video intended to explain the importance of naming conventions and identifiers for biosimilars, stating, “. . . a switch. This carries risks, given that no two biologic medicines are identical, and thus can behave differently in the body. Switching drugs is not a good idea if your medicine is working for you.”
Pfizer requested FDA that it should address in the guidance include misleading representations and suggestions by reference product sponsors that biosimilar products are not as safe or as effective as their corresponding reference biologic products. Because the licensure of a biosimilar product is predicated on a determination that there are no clinically meaningful differences between the biosimilar and its reference biologic in terms of safety, efficacy, or purity, any promotional statements by a sponsor that directly or implicitly communicate that biosimilar products are not as clinically safe or effective as the corresponding reference product are false and misleading, and therefore in violation of the FD&C Act and FDA regulations.
Pfizer also asked FDA guidance to address reference product sponsor communications comparing reference biologics to biosimilars, including interchangeables, that would and would not be considered misleading. The Agency should specify, for example, that reference product sponsor representations or suggestions that biosimilar products are inferior to interchangeable biologics in terms of quality or similarity to the reference product would be misleading and therefore in violation of the FD&C Act.
