Topics:

EU regulators give landmark backing to Remicade biosimilars

Tools

Two developers of biosimilars won a major victory in Europe. A European Union regulator backed approval of two copycat versions of Johnson & Johnson's ($JNJ) blockbuster therapy Remicade, meaning the healthcare giant could face competition from new low-cost rivals in the European market.

The European Medicine Agency's positive recommendation marks the very first blessings for monoclonal antibody biosimilars as well as the first knockoffs of Remicade, Bloomberg reported. South Korean biotech Celltrion won the EMA's support for its Remicade biosimilar called Remsima and the U.S. company Hospira ($HSP) gained backing for its own biosimilar dubbed Inflectra. The European Commission is expected to follow the EMA committee's advice and approve the products for a bunch of autoimmune diseases, including rheumatoid arthritis and Crohn's disease.

Major biopharma companies have been seeking avenues to hold off biosimilar versions of their best-selling drugs for years, with arguably more success in the U.S. than in Europe, where a dozen or so copycat biologics have won approvals. The U.S., however, has yet to provide a clear picture of how the agency will decide whether a biosimilar is close enough to the reference biologics to gain market approval. Unlike small-molecular generics, biologics are made from living cells and are impossible to copy exactly. Even if approved, biosimilars face marketing hurdles and other expenses that could cut into profits.

Remicade could be the first in what is expected to be a string of blockbuster biologics to encounter biosimilar competition. Johnson & Johnson, which markets the $6 billion drug in partnership with Merck ($MRK), has options on the table to fight off competition. The therapy has patent protection in most EU countries until February 2015 and in the U.S. until September 2018, noted Mark Purcell, an analyst for Barclays, as cited by Bloomberg. And J&J could mount legal actions against biosimilars to keep them from the market.

Still, the market entry of Remicade knockoffs seems more inevitable than ever today. Especially in Europe, where authorities have embraced measures to reduce prescription drug costs.

"The price of Remsima will be more than 30 percent cheaper than those of the original drugs," Kim Hyoung Ki, senior vice president and chief financial officer at Celltrion, told reporters in Seoul today, as quoted by the news service. "We're confident in Remsima as it has price competitiveness, while it has the same effect as the original drugs."

- here's the release
- check out Bloomberg's article
- and the update from Reuters

Related Articles:
Roche sees another Rituxan biosimilar trial bite the dust
Sandoz bulls ahead with full slate of PhIII biosimilar studies
Biotechs beat generics rivals in state biosimilars battle
J&J credits Remicade, Zytiga for 7% hike in Q3 drug sales
J&J drug sales hold their own, thanks to foreign growth