FDA Panel Backs Lower-Cost Version of J&J’s Top-Selling Drug

Federal health advisers on Tuesday endorsed a lower-cost version of Johnson & Johnson’s blockbuster Remicade, a pricey biotech medicine used to treat a number of inflammatory diseases.

The non-binding recommendation could clear the way for the cheaper medication from Celltrion, which would only be the second in a new class of quasi-generic biotech drugs to reach the U.S. market. These drugs, already available in Europe, have the potential to generate billions of dollars in savings for insurers, doctors and patients in coming years.

Biotech drugs are powerful, injected medicines produced in living cells which are typically much more expensive than traditional chemical-based drugs. In 2014, six of the 10 best-selling medicines globally were biologics, with about $49 billion in combined sales.

Remicade is approved for psoriasis, rheumatoid arthritis and five other conditions in which the immune system attacks the body’s own tissue. The drug helps reduce inflammation and control the immune system, which helps slow these diseases.

After nine hours of discussion, the FDA panel of outside experts voted 21–3 in favor of treatment approval for all the diseases currently indicated on Remicade’s label.

Despite the majority vote, many experts said they would like to see more information on the new drug’s performance against certain diseases, particularly irritable bowel disorder.

FDA scientists attempted to assure the panel that Celltrion’s data virtually assured the drug would work as well as Remicade across multiple diseases, even without formal studies showing those results.

“The clinical data would only provide assurance for what we already know to be true, that the drug works,” said Dr. Badrul Chowdhury, a director in the FDA’s office of drug evaluation.

The FDA concluded in its own review that Celltrion’s drug is “highly similar” to Remicade, the standard needed for approval.

For decades, biotech drugs lacked generic competition because the FDA had no system to approve cheaper versions. That changed in 2012 and the agency finally approved the first “biosimilar” last March. Biosimilar is the industry term for generic biotech drugs, used to indicate that they are not exact copies of the original biologic medicines.

Remicade had worldwide sales of $6.56 billion last year, down more than 4 percent due to overseas competition from biosimilar versions already sold by Pfizer and Celltrion.

Korea-based Celltrion Inc. sells its biosimilar under the brand Remsima in 50 countries, including Canada, Japan and Europe

Wells Fargo analyst Larry Biegelsen expects Celltrion’s version to launch in the second half of 2016 and to reduce sales of Remicade by 10 percent to $4.2 billion by the end of 2017.

A key factor in uptake of the new drug will depend on whether it is reserved for first-time patients or whether patients already on Remicade are switched to the cheaper medication. Many states are still deciding whether pharmacists can substitute a biosimilar for the original biologic drug without the prescribing doctor’s permission, as usually happens with generic pills.

Other blockbuster biotech drugs expected to face U.S. competition in coming years include AbbVie’s anti-inflammatory drug Humira, which is from the same family as Remicade. Humira was the best-selling drug in the world last year, with sales of $14 billion.

Top pharmaceutical companies including Novartis, Pfizer Inc. and Merck & Co., which all make their own biologic drugs, are developing biosimilars of rival companies’ top biologics.