Antitrust Lawsuits on Increasing Biosimilar Accessibility

In an interview with The Center for Biosimilars^®, intellectual property lawyer, Ha Kung Wong, JD, partnered with Venable LLP, discusses the impact of lawsuits on biosimilar accessibility. He mentions a recent lawsuit by Johnson & Johnson (J&J), aiming to delay biosimilar competition and other relevant legal cases.

Wong points out that antitrust suits targeting biosimilar competition are not uncommon, especially for expensive drugs. He then elaborates on 3 past lawsuits: J&J’s antitrust suit regarding Remicade (reference infliximab), the Remicade exclusionary contracting lawsuit by Pfizer, and the lawsuit regarding Humira (reference adalimumab).

While these lawsuits might have discouraged the use of exclusionary contracts, their effectiveness remains debatable due to relatively small settlements compared to the drugs' revenue. The interview concludes surrounding the uncertainty of future lawsuits' and the impact they have on biosimilar accessibility.

Transcript:

Recently, CareFirst BlueCross BlueShield filed a lawsuit against J&J alleging that the company is “scheming” to delay ustekinumab biosimilar competition. How do you expect this case to play out and what impact could it have on the overall biosimilar industry?

This is not the first antitrust suit to be filed related to a biosimilar and biosimilar competition, particularly on drugs that are costly so it really isn't surprising to see another antitrust suit.

As a side note, talking about antitrust always reminds me of the 2001 movie Antitrust starring Ryan Phillippe and Rachael Leigh Cook, but I digress.

Previous antitrust suits, you know that I think we want to think about in conjunction with this one would be the Remicade exclusionary contracting class action lawsuit. That actually was settled by consumers, third party payers for $25 million.

There was the Remicade exclusionary contracting lawsuit by Inflectra biosimilar manufacturer, Pfizer. There was an undisclosed settlement agreement there.

Then the Humira lawsuit, which found that filing numerous patent applications was a form of petitioning the government, qualified for Noerr-Pennington immunity and that protects the filing under the First Amendment petition and free speech clause.

Even if the petition is anticompetitive, it's immune from antitrust action. I bring those up because so far, the biosimilar antitrust suits may have had some positive impact on decreasing the usage of exclusionary contracts to prevent biosimilar formulary coverage.

However, it's yet to be seen maybe debatable how steep of a deterrent something like a $25 million settlement is on a drug similar to Remicade, which is making over $6 billion a year.

It’s unclear whether another antitrust lawsuit will have a significant impact on biosimilars going forward or not. But certainly something that we should keep an eye on and certainly something we should be vigilant about.