FDA’s naming rule on biosimilars has undermined competition – Boston, Massachusetts

Boston, Massachusetts 2021-10-04 04:50:48 –

Me I recently tried to order biosimilar leukocyte growth factor (pegfilgrastim) from one of my patients. This is a drug that helps prevent fever and infections associated with low white blood cell counts.

For years it was easy to prescribe it. Because the only option was the branded drug Neulasta brand pegfilgrastim. However, Neulasta’s patent expired in October 2015, and there are now several FDA-approved biosimilars on the market. ..

Each is pegfilgrastim, On request of FDA guidance, Each of the biosimilars and the originator itself Random 4-character suffix.. Congress’s intention was to create a biosimilar usage equivalent to generics, but healthcare providers now need to order a specific version that includes the suffix. Further complicating the process, prescribers have no idea which version will be covered by the patient’s insurance company.


How did you get into this complicated and confusing situation?As part of an affordable care law, Congress Biopharmaceutical price and competitive innovation law This created a new pathway for the approval of biosimilar molecules. This is functionally equivalent to the brand name “Originator” biopharmaceutical. These are biologically active polymers such as antibodies, receptors, and ligands that are not chemically synthesized but are produced in culture by mammalian or microbial cells. Biosimilars are not eligible as generics under the 1984 Hatchwaxman Act because they are not exactly molecular copies like generics.

That may be true under the wording of the law, but it must be pointed out that all biologics undergo small chemical changes over time — today’s New Rasta was created a few years ago. Not the same as the new raster.


The Biologics Price and Competition Innovations Act has created a accelerated approval process for biosimilar molecules. This requires the submission of extensive chemical and manufacturing data, as well as the results of one clinical trial for the approval of currently turned off approved drugs and biomolecules whose structure and activity are biosimilars. was. Patent protection. Once approved, biosimilars will be approved for all use of the originator molecule as specified in the Package Insert, not just those used in clinical trials. The goal of this law and subsequent FDA regulations is to significantly reduce the cost of developing biosimilar medicines.

Unfortunately, due to compatibility concerns (switching between originator and biosimilar) and pharmacovigilance (toxicity monitoring), the process is not on track. State law or hospital policy may allow generics to replace branded drugs without special approval from the prescribing, but the FDA can switch back and forth without losing biosimilar and originator molecules. Requested additional complex testing to show. Clinical effect.

Exchangeability can be easily demonstrated with biological agents such as insulin that can monitor glucose levels hourly, but cancer and rheumatism drugs whose results are clinical benefits that have been demonstrated over months or years. Is virtually impossible.

Nevertheless, the FDA now requires all biologics to have a four-letter suffix in addition to the generic name that identifies it to regulators. Since there is no data to compare one biosimilar with another, doctors and pharmacists must assume that it works like any other biosimilar. Also, because each has its own identifier, doctors need to not only order “pegfilgrastim”, but instead request a specific identifier and know what the patient is insured at that time. Yes (this is subject to change at any time without notice).

The suffix also means that each biosimilar is an individually identifiable drug and that the drug company is adopting the following strategies: Brand biosimilar.. This, in addition to the suffix, leads to a confusing brand name surge.

My colleague, doctor Michael Kane, who heads the oncology pharmacy at RWJ Barnabas Health, said the biosimilar system would cost about $ 2 million a year for a medium-sized medical system with additional labor costs, refusals to refund, and the need. Told me Stock multiple versions of each biosimilar to comply with the arbitrary requirements of third-party payers.

Is this really necessary? Is the concern about switching from a biosimilar to another biosimilar in the middle of treatment reasonable? None of the companies that manufacture oncological biosimilars have done compatibility testing, so no one knows.

Regulations requiring the use of discriminative suffixes instead of providing a simpler system for prescribing biosimilars result in an excess of brand names and suffixes for each biosimilar in unpatented biopharmacy. Competition that has created more jobs, greater turmoil, and less markets. Instead of all biosimilars competing as one drug pool, there are now five “brand” branded pegfilgrastim, each competing as a unique drug on the market. Isn’t it strange that the advent of biosimilars did not bring the expected savings to the medical system?

This week I was finally able to approve pegfilgrastim-cbqv (Udenyca) to the patient and cover it with patient insurance, but only after many phone calls to the insurance company. Now I just want it to be delivered in time.

Howard S. Hoxter is an oncology scholar, director of oncology research at RWJ Barnabas Health, NJ, deputy director of the Rutgers Cancer Institute, and a prominent medical professor at the Rutgers Robert Wood Johnson School of Medicine.

FDA’s naming rule on biosimilars has undermined competition Source link FDA’s naming rule on biosimilars has undermined competition

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