First Biosimilar in the United States Helps Fight Cancer

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The first biosimilar, Zarxio is now available in the US to assist in the fight against cancer, but it hasn’t been an easy road for Sandoz, a Novartis company, that brought it to market.

If you aren’t sure what a biosimilar is, you are not alone. The FDA defines a biosimilar product as “a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.” Since biosimilars are copies of biologic products, which are made of living cells, they are not considered exact duplicates. Insurers hope they will cost the public 40 percent to 50 percent less than the original brands.

Sandoz is counting on these costs saving to boost sales. ”While biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general.  Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies,” said Dr. Ralph Boccia, Medical Director of the Center for Cancer and Blood Disorders, and Chief Medical Officer for the International Oncology Network (ION). Zarxio is entering the crowded and lucrative cancer market, the drug it matches is Filgrastim, a drug that fends off infections in cancer patients. Filgrastim helps your body make white blood cells to help prevent infections during cancer treatments (chemotherapy). Richard Francis, Global Head, Sandoz says, “With the launch of Zarxio, we look forward to increasing patient, prescriber and payor access to filgrastim in the US by offering a high-quality, more affordable version of this important oncology medicine.”

Amgen, who announced a partnership in the areas of migraines and Alzheimer’s with Novartis (Sandoz’s parent company) yesterday, has a filgrastim drug, Neupogen, and was not happy about the biosimilar’s entry into the market. Last October, Amgen, for who Neupogem represents $1.2 billion-a-year in income, sued Sandoz in district court in San Francisco, saying Zarxio infringed the patent on Amgen’s drug. The court refused to grant a preliminary injunction barring the sale of Zarxio while the lawsuit continued, but in May the injunction was granted by the U.S. Court of Appeals for the Federal Circuit. That court finally handed down a ruling against Amgen that finally opened the door for the Sandoz launch. A second appeal by Amgen was also rejected.
The court case focused on whether Sandoz had made appropriate disclosures to Amgen that it planned to bring out a copy of Neupogen, as the law requires. Sandoz lawyer Deanne Maynard of Morrison Foerster said the company had done so twice, once when it applied for approval for Zarxio from the Food and Drug Administration and again when it received that approval.

Arguing for Amgen, Nicholas Groombridge of Paul, Weiss, Rifkind, Wharton & Garrison said Sandoz had failed to follow regulations about how notice is to be given on the launch of a biosimilar. The court eventually agreed with Sandoz.

The court case makes sense in terms of the amount of money at stake. The global market for cancer drugs has hit $100 billion in annual sales, and could reach $147 billion by 2018, according to a new report by the IMS Institute for Healthcare Informatics, a unit of drug data provider IMS Health. It’s a crowded market and trying to limit the competition makes sense.

FDA approval of Zarxio occurred in March 6, 2015 but the court case held up their launch. The approval, via the new biosimilars pathway established under the Biologics Price Competition and Innovation Act, was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar with no clinically meaningful differences to the US-licensed reference product.  The successful Sandoz pivotal head-to-head PIONEER study was the final piece of data contributing to the totality of evidence used by FDA to approve Zarxio as biosimilar to the reference product. Importantly, the data demonstrating high similarity was sufficient to allow extrapolation of use of Zarxio to five indications of the reference product.

The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amended the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.

A new report by Visiongain found that Sandoz is the current market leader among biosimilar drug producers, with an estimated revenue there of $0.43bn for 2014. In addition to Zarxio, Sandoz currently markets three biosimilars outside the US. Sandoz has a leading pipeline with several biosimilars across the various stages of development, including five programs in Phase III clinical trials/filing preparation.

The Visiongain study finds companies that operate in the biosimilars market are becoming more consolidated, as the leading pharmaceutical companies react to the threat of potential market entrants in the developing biosimilar market. This will see the entrance of more big pharma corporations, as they acknowledge the growth of the biosimilar industry and the threat those follow-on biological medicines pose to their innovative biological drugs (biologics).

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Lindsey McCoy MPA, is an Executive Medical Recruiter and former Executive Director in the not for profit sector.

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