The Food and Drugs Administration (FDA) has approved this Tuesday a cheaper version of Johnson & Johnson’s Remicade under the name of “Inflectra” which consist on a pricey biotech medicine that helps reduce inflammation and control the immune system to slow down some diseases.
The Inflectra is a treatment for reducing the signs and symptoms of patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and also adult and pediatric Crohn’s Disease.
The Johnson & Johnson’s Remicade was approved in 1998 and is one of their top-selling medicines with sales of $5.65 billion last year, where they slipped about 4% in 2015 due the overseas competitors from the South Korean-based Pfizer and Celltrion Inc.
For decades, the biotech drugs have been lacking a generic competitor; the FDA doesn’t have a system to approve cheaper versions of drugs – being this the main reason of this.
But are the biosimilar generics? CEO of Johnson & Johnson’s Alex Gorsky explained that it isn’t; about 70% of Remicade patients have had a pretty high satisfaction rate and they might not jump ships because of this.
Jenny Alltoft, head of Pfizer said that their experience in other markets around the world has demonstrated that the biosimilars are well received by their patients, physicians and others; Pfizer is proud to play a leading role on the U.S market with their biosimilars, committing the company to bring these important medicines to their patients as quick as possible.
What’s a biosimilar drug?
A biosimilar is nothing but a biological product that is derived from a living organism that can come from many sources that includes humans, animals, microorganisms or yeast.
Now, a biosimilar drug is a product that is approved based on an already-approved “reference product” – in this case being the Remicade the reference product –. The Inflectra before being approved had to show the same clinical features, especially in terms of safety and effectiveness that the reference product, but it may also allow a few minor differences in the clinically inactive components.
The FDA approved this biosimilar after the reviews they got from a structural and functional characterization of the human study data, as well with the pharmacokinetic and pharmacodynamics data, clinical immunogenic data and other safety and effectiveness data that really demonstrates that the Inflectra is biosimilar to the Remicade – as well as being a cheap-but-effective alternative.