FDA Approves New Biosimilar That Could Save the U.S. Billions

<img class="aligncenter wp-image-2416" src="https://mdthinks.com/wp-content/uploads/2017/12/fda-approves-new-biosimilar-that-could-save-the-u-s-billions.jpg" alt=" FDA approves new biosimilar that could save US billions "width =" 446 "height =" 336 "/> FDA has just approved a release Enbrel, the successful arthritis drug manufactured by Amgen that brought in $ 5 billion in sales in 2015.

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The newly approved drug, manufactured by Sandoz Division of Novartis, will be marketed under the name of Erelzi. This is a type of medicine called "biosimilar", which looks like a generic version of a biological drug, a drug produced by living cells.

Biosimilars are a little more complicated than the average of competing drugs: unlike generic drugs for chemical drugs such as antibiotics, which may be interchangeable with branded versions, imitations of biologic drugs have some reservations.

This new biosimilar is now approved to treat, according to the FDA, the same conditions that Enbrel is authorized to treat:

moderate to severe rheumatoid arthritis
moderate to severe polyarticular juvenile idiopathic arthritis
active psoriatic arthritis
active ankylosing spondylitis
chronic moderate to severe plaque psoriasis in adults

It is now the third biosimilar that the FDA has approved.

Earlier in 2016, the FDA approved a version of Remicade, or infliximab, a drug used to treat autoimmune diseases such as Crohn's disease and rheumatoid arthritis. Another called Zarxio (also manufactured by Sandoz) was approved in 2015. In July, the FDA organized panels that recommended that the agency approve this biosimilar, as well as a biosimilar for another autoimmune drug called Humira.

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There is no definite timetable for when Sandoz will be able to start putting Erelzi on the market, as there are legal disputes surrounding the drug. In response to this award, a spokeswoman for Sandoz said, "It is too early to speculate on Erelzi's price." That being said, we believe that patients in the United States can benefit greatly from the benefits of the drug. a competitively priced anesthetic manufactured in accordance with strict GMP and high quality standards. "

And a spokeswoman for Amgen said in a statement: "We have confidence in our Enbrel-related patents and are currently in litigation with Sandoz to enforce our patent rights." Immunex / Amgen and Sandoz said. entered into an agreement relating to a preliminary injunction relating to Sandoz's etanercept, as set out in the order of the Court dated August 11, 2016. "

Having more biosimilars in the United States would be a big problem: it could be the best way to reduce the cost of biologic drugs (usually very expensive) that have been around for some time. Savings on less expensive biosimilars – even new patients who have never taken the original – are estimated at billions of dollars.

What differentiates biosimilars from generics

Developing a biosimilar is not as easy as creating a generic imitation; because you work with complex living things, making a copy is not so simple.

"When you have a small molecule like Lipitor, you know where each atom is," said Dennis Lanfear, CEO of biosimilar company Coherus Biosciences, at Business Insider in April. Generic versions of drugs like this one can be chemically identical.

This is not the case with something like a monoclonal antibody – a type of protein produced in the lab that can go after certain cells like your immune system – that can vary greatly. This means that you have to run the biosimilar through a bunch of studies to prove that it is doing the same thing as the original drug.

Coherus develops biosimilar versions of drugs for autoimmune diseases and cancer treatment, including biosimilar versions of Humira and Enbrel. He plans to file a biological license application with the FDA for his version of pegfilgrastim, a bone marrow stimulant, in 2016.

"Biosimilars are here," said Lanfear. "They are now here today, the simplest ones have been approved, like Zarxio, and the complexes have also been approved."

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