September 17, 2021

'Patent Dance' Create Hurdles to Biosimilar Drug Launches

By Kimberly Firtz, PharmD, MSPBA Candidate
Published Online: Wednesday, May 16, 2018

In an unprecedented unanimous ruling on June 12, 2017, the Supreme Court ruled that biosimilar drug manufacturers applying for approval from the FDA “may provide notice of commercial marketing to the branded biologic drug manufacturer before obtaining a license.”

This ruling was significant for all stakeholders in the health care space. From biologic and biosimilar drug manufacturers, to payers, providers, pharmacies, and, most importantly, patients requiring these medications, this ruling will have a lasting impact.

The precedent set during this case allows for an increase in the speed to market for biosimilar drugs by up to 180 days. To understand the impacts that this case will have on the future of biologics and biosimilars, let’s first take a step back and discuss biologic and biosimilar drugs.

Biologics and Biosimilars

According to the FDA website, “Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.”

Biologic medications differ from traditional medications in that they are isolated from natural living sources rather than being chemically synthesized. Biologics are produced by biotechnology methods and are typically very large mixtures of molecules.

Unlike simple chemical structures that can be drawn in an organic chemistry class, biologics are typically comprised of tens of thousands of atoms. They typically have strict storage and handling requirements, as many need to be stored at a certain temperature and may be injected or infused; therefore, they must remain sterile from manufacturing through delivery.

All of these attributes make biologic medications more difficult to manufacture, dispense, and deliver. It also makes them very difficult to replicate and reproduce.

Although biologics are extremely difficult to replicate, it is valuable to produce similar molecules with the same targets as these biologic drugs to bring additional competition to the market. The difficulties surrounding the manufacturing and handling of these drugs make them extremely expensive and the high cost makes it difficult for patients to gain access to them.

Introducing additional competition can greatly decrease cost and, therefore, improve patient access. In order to fulfill this need, many pharmaceutical manufacturers worked to create drugs similar to biologics, referred to as biosimilars.

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