Expanding Biosimilar Market May Drive Down the Cost of Treatment

This past week, advisory panels to the Food and Drug Administration gave unanimous recommendation for biosimilars of both Abbvie’s Humira, and Amgen’s Enbrel.1

Biosimilars are nearly identical copies of original biologic medications. The biologics Humira and Enbrel are used commonly in the treatment of conditions such as Rheumatoid Arthritis. Both Humira and Enbrel are two of the highest grossing drugs in the world, with combined sales nearing $23 billion dollars globally in 2015.2

Drug firm Amgen aims to produce the Humira copy, and Sandoz, the generic pharmaceutical division of Novartis, aims to produce the Enbrel copy.3

Though both drugs received recommendation, an FDA advisory panel is part of a preliminary process of approval. “The final decision will come from the FDA, and although it does not have to follow the advice of its panel, it typically does. The agency is slated to make a final decision by Sept. 25.”4

It may be years before these drugs arrive on the market should they receive final approval. Currently “Amgen is suing Novartis’ generic and biosimilar unit Sandoz on the grounds that its biosimilar infringes several of Enbrel’s patents.”5 Abbvie’s CEO Richard Gonzales says that the patent on Humira protects their market share until 2022, and that they intend to defend the patent from biosimilar manufacture.6

Slow progress aside, increased competition and cheaper treatment options should save money for consumers in the years to come. However, uncertainty exists as to how great those savings will be. The U.S. is just now entering the biosimilar marketplace, and the European Union has only had biosimilars since 2006. “Overall, in the European Union and other countries, biosimilars are priced at about a 25–30% discount relative to their reference products.”7 The U.S. market will be different, with variations on policy, marketing, and insurance. Any prediction on cost differences between the original drug and the biosimilar is difficult at this time.

It seems likely that many insurance companies will require patients to use the less expensive biosimilars, just as they do with generics of other medications. Changing over to the cheaper products will likely be reflected in out of pocket costs.

Pending the probable outcome of FDA approval, the next decade will see a shift in the marketplace, with the biosimilars of Humira and Enbrel paving the way for RA treatments.

 

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The RheumatoidArthritis.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.
View References
  1. Back to back: FDA panel offers unanimous thumbs up op for Sandoz'a Enbrel biosimilar. July 15, 2016. http://www.pharmacist.com/back-back-fda-panel-offers-unanimous-thumbs-sandozs-enbrel-biosimilar
  2. Copycat of AbbVie's Humira and Amgen's Enbrel May Soon Win FDA Approval. Fortune. Retrieved July 15, 2016. http://fortune.com/2016/07/15/abbvie-humira-amgen-enbrel-biosimilars/
  3. Copycat of AbbVie's Humira and Amgen's Enbrel May Soon Win FDA Approval. Fortune. Retrieved July 15, 2016. http://fortune.com/2016/07/15/abbvie-humira-amgen-enbrel-biosimilars/
  4. FDA panel backs Amgen's Humira copy, but don't expect to see it anytime soon. Fierce Biotech. July 13, 2016. http://www.fiercebiotech.com/biotech/fda-panel-backs-amgen-s-humira-copy-but-don-t-expect-to-see-it-anytime-soon
  5. FDA panel backs Amgen's Humira copy, but don't expect to see it anytime soon. Fierce Biotech. July 13, 2016. http://www.fiercebiotech.com/biotech/fda-panel-backs-amgen-s-humira-copy-but-don-t-expect-to-see-it-anytime-soon
  6. Abbvie CEO: Humira Biosimilars Won't Reach Market Until at Least 2022. Biopharmaceutical International. Nov 03, 2015. http://www.biopharminternational.com/abbvie-ceo-humira-biosimilars-won-t-reach-market-until-least-2022
  7. U.S. Biosimilars Future is Hard to Predict: Global Health Policy, Innovation, Prices, and Profits are All at Stake. Bioprocess International. Dec 11, 2014. http://www.bioprocessintl.com/manufacturing/biosimilars/us-biosimilars-future-hard-predict/

Comments

View Comments (2)
  • marcia ewell
    3 years ago

    Finally! My brilliant pharmacist has some interesting insight into biosimilars. Years ago, when Amgen’s Enbrel patent was coming up for expiration, but got denied, he told me it was because Amgen ‘mislead’ the FDA by claiming nobody else could be able to make Enbrel because of the “biologic’ nature of the drug. He said that was bunk and explained that not even Amgen can make Enbrel the same as each batch as it is ever so slightly different as it is a living product with slight variations from batch to batch. I then asked how much does it really cost to make a syringe of Enbrel, He said about $5/syringe,mostly due to the china made outsourced syringe. They nw retail for over $4000 for 4 syringes. He said it was just Big Pharma trying to maximize their profits at the expense of the sick and suffering Americans, and anywhere else in the world you buy the same US made Enbrel for a fraction of what we pay. We have an “affordable health care act’ that forgot to include price caps to prevent abusing the sick who need these meds. I think the biggest reason our medicare/SS system is at risk, is because the government is required to pay full retail reimbursement back to big pharma for medicare/medicaid meds people need. I appreciate your honest opinion that by the time the biosimilars hit the US market,there will probably not be much saving to the people who need these meds. We need a single payer system so we can remove the profit driven greedy middle men who are ripping us all off. I am hoping Hilary might just do the right thing and finish what she started, if she has a sense of right and wrong?? If not, I might have to be an expat someday soon to avoid medical bankruptcy.

  • Michael Booth moderator author
    3 years ago

    Hi Marcia Ewell, thank you for your comment and taking the time to share. I certainly hope that when biosimilars hit the market, the cost of treatment will come down and many who are denied or can’t afford drugs that could help them, will be relieved of that problem. Given the complicated nature of healthcare, policy, politics, insurance systems, and the market, it seems we will have to wait and see what happens. Best wishes to you, and thank you again for your comment! — Michael

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