Pfizer, J&J, Amgen and Roche Start a Bare-Knuckle Brawl Over Biosimilars

Fist fight

In August, Pfizer filed with the U.S. Food and Drug Administration (FDA) accusing Amgen and Roche of using social media to mislead doctors and patients about biosimilars and their effectiveness.

Biosimilars are essentially generic versions of biologic drugs. However, unlike generics of small molecule drugs, biosimilars are not exact copycats, but are “similar,” and as a result, have to undergo a regulatory approval process like that of new drugs.

Europe began approving biosimilars in 2006, but the U.S. has lagged behind, only starting to approve biosimilars in 2015. There are still only a dozen biosimilars approved in the U.S., but some of them have not hit the market due to legal maneuvering on the part of biopharma companies that market the drugs being copied.

Bloomberg writes, “One Amgen tweet Pfizer flagged to U.S. regulators says biologics and biosimilars aren’t ‘just apples to apples.’ And an Amgen message on YouTube told patients, ‘Switching drugs is not a good idea if your medicine is working for you,’ and warned about side effects or confusion among doctors. The ‘bottom line is patient safety,’ Amgen says in the video.”

When Pfizer acquired Hospira in 2015 for $17 billion, part of the reason was to make a strategic entry into the biosimilars markets. But the entry has turned out to be much more difficult than expected, largely because of the tactics other companies are using.

“We feel it’s important to officially address misleading and deceptive marketing tactics by certain originator companies,” Lisa Skeens, regulatory affairs lead for Pfizer Essential Health, told Bloomberg.

Vamil Divan, an analyst with Credit Suisse AG, notes that slightly less than a third of $293 billion in annual global biologic sales will lose patent protection by 2023. This, Divan told Bloomberg, is “leaving the door wide open for biosimilar competition.”

Pfizer has projected a global biosimilar market by 2020 of $20 billion, but only if it can get past its competitors' defenses.

Johnson & Johnson was also included in Pfizer’s complaints, although not, apparently, over its social media. Rather, Pfizer noted that a J&J patient brochure attempted to “sow doubt and confusion” about biosimilars. The brochure targeted patients being asked to change from a brand-name drug to a biosimilar, specifically Remicade. Remicade is a J&J drug for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and ankylosing spondylitis. Biosimilars for Remicade include Merck & Co.’s Renflexis (infliximab-abda). Another is Pfizer’s Inflectra (infliximab-dyyb) that came out of Hospira and Celltrion.

It’s worth pointing out that biopharma companies do not generally couch their biosimilars in terms of being competing products, or even necessarily for being less expensive than the brand-name drugs. They often offer comments on how they are providing savings for the health care system, suggesting that the audience isn’t patients, but government payers and insurers. An example is Dora Bibila, general manager of Merck Biosimilars, saying in a 2017 statement, “Merck believes that biosimilars have the potential to help increase access to these important medicines while also providing savings for the health care system. Merck looks forward to launching Renflexis in the United States to help meet the needs of patients, physicians, and payers.”

Pfizer is also accusing Pfizer of using “exclusionary” contracts with hospitals and insurance companies that require bundling Remicade coverage with other products—the threat being that if they don’t include Remicade, they’ll lose access to other J&J products.

For its part, the FDA is concerned about the slow penetration of biosimilars into the U.S. market. In January, it implemented its Biosimilar Innovation Plan. It included new draft guidance, attempted to decrease the regulatory obstacles, and improve the efficiency of its generic review program.

In May, however, Christine Simmon, executive director of the Biosimilars Council, a division of the Association for Accessible Medicines, writing for STAT, noted that companies had four broad tactics they were using to fend off biosimilar competition. Those four tactics were:

  1. Gaming the FDA’s Risk Evaluation and Mitigation Strategies.
  2. Patent expansion. Biopharma companies are filing more “non-innovative” patients on the drugs they want to protect.
  3. Rebate traps. Simmons wrote, “Upon market entry of a competitive biosimilar, some brand manufacturers have threatened to remove the rebates they provide to payers unless the biosimilar is effectively excluded from the market.”
  4. Distorted marketing.

Simmons wrote, “These barriers have forced the U.S. biosimilars industry into a perpetual state of infancy and cost patients and taxpayers more than $5 billion each year.”

It shouldn’t really come as a surprise that the big players in a multi-billion-dollar industry are fighting hard for every edge. Or, as Douglas House, Seeking Alpha news editor wrote, “As always, the drugs business is a bare-knuckle fight.”

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