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The basics of biosimilars
Four things you should know about the next wave of treatment for chronic diseases
Biosimilars are developed under the Biologics Price Competition and Innovation Act
The Biologics Price Competition and Innovation Act, signed into law under the Patient Protection and Affordable Care Act in 2010, creates an abbreviated approval pathway for biologic products demonstrated to be “highly similar” to an FDA-licensed biological product. The rationale behind the new law is to provide a shortened route of approval for biosimilar products that saves time and resources by avoiding duplication of human or animal testing, according to the FDA.
“The heavy lifting has been done by the originator compounds in terms of these large, global clinical trials,” Leonard H. Calabrese, DO, vice chair of rheumatic and immunologic disease at Cleveland Clinic, told Healio.com in an interview. “The clinical trials that are demanded of biosimilars are much smaller ... then by extrapolation they are approved for all of the same indications as the originator compound, and thus they can be produced for a smaller amount of money and pass along those savings to the consumers.”
Unlike generics, biosimilars are not exact copies of the originator compound
Because biosimilars are required to demonstrate a high rate of similarity to their reference products, there are no clinically meaningful differences in terms of safety, purity and potency. However, biosimilars are very different than generic drugs in that biologic compounds are created in living cells, so it is impossible to make an exact copy, Stephen B. Hanauer, MD, Clifford Joseph Barborka Professor at Northwestern University Feinberg School of Medicine, told Healio.com.
Although one biosimilar may be highly similar to a biologic agent, it may not have the same effects on patients as another biosimilar, even if it is being used to treat the same chronic diseases. That is why specific naming conventions, as well as consulting with a physician before switching a patient’s biosimilar, are important, according to Hanauer.
Five biosimilars are approved in the U.S.
As of this publication, five biosimilars are currently approved for use in the United States: filgrastim-sndz (Zarxio, Sandoz Inc.) is biosimilar to filgrastim (Neupogen, Amgen Inc.) and was the first biosimilar approved by the FDA in March 2015. The FDA then approved infliximab-dyyb (Inflectra, Celltrion Inc.) — a biosimilar to infliximab (Remicade, Janssen Biotech Inc.) — in April 2016. Next came etanercept-szzs (Erelzi, Sandoz Inc.) — a biosimilar to etanercept (Enbrel, Amgen Inc.) — in August 2016, and adalimumab-atto (Amjevita, Amgen Inc.) — a biosimilar to adalimumab (Humira, AbbVie) — in September 2016. In April 2017, the FDA approved infliximab-abda (Renflexis, Samsung Bioepis) — an injectable biosimilar to infliximab.
Despite approval, some biosimilars remain unmarketable because their originator products are still under patent. However, as patents expire on originator drugs there will be more opportunities for the use of biosimilars, Calabrese explained.
Biosimilars could save the U.S. $13 to $66 billion on biologics spending
According to a perspective released by the Rand Corporation in 2014, biosimilars are projected to reduce U.S. spending on biologic agents by $44.2 billion dollars between 2014 and 2024 – that’s about 4% of total biologic spending, with a range from $13 to $66 billion. However, the authors cautioned the true cost savings will depend largely on sales, the degree of competition and the timing of biosimilar entry to the market.
In Europe, the implementation of biosimilars has led to a 30% to 50% reduction in the cost of biologic agents, according to Hanauer.
“Now, frankly, when you apply this to the U.S., this is not going to mean a 30% to 50% reduction in cost to patients,” he said. “It is going to end up being a reduction in the cost to the insurance companies and to the pharmacies who will be able to purchase these at a lower cost from the originator compound. And secondarily, that should allow more patients to have access to these drugs.”
Calabrese noted the reduction in the cost of biologic agents will cause originator companies to pare down their prices, although currently those prices have increased 15% to 16% per year with no additional investments by the company. – by Casey Tingle
References:
Biosimilars Forum: Frequently asked questions. Biosimilars Forum website. http://www.biosimilarsforum.org/sites/default/files/uploads/biosimilars_faqs_032816opt_0.pdf. Accessed Sept. 16, 2016.
Calabrese L. Biosimilar update. Presented at: Rheumatology Nurses Society Annual Meeting; Aug. 3-6, 2016; Cleveland, Ohio.
FDA approves first biosimilar product Zarxio. FDA website. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm. Accessed Sept. 21, 2016.
FDA approves Inflectra, biosimilar to Remicade. FDA website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm. Accessed Sept. 21, 2016.
FDA approves Erelzi, a biosimilar to Enbrel. FDA website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm. Accessed Sept. 21, 2016.
Mulcahy AW, et al. The cost savings potential of biosimilar drugs in the United States. Rand Corporation website. https://www.rand.org/content/dam/rand/pubs/perspectives/PE100/PE127/RAND_PE127.pdf. Accessed October 19, 2016.
For more information:
Leonard Calabrese, DO, can be reached at Cleveland Clinic Main Campus, Mail Code A50, 9500 Euclid Ave., Cleveland, OH 44195; email: calabrl@ccf.org.
Stephen B. Hanauer, MD, AGAF, FACG, can be reached at Northwestern University Feinberg School of Medicine, 303 E. Chicago Ave., Chicago, IL 60611; email: shanauer@northwestern.edu.
Disclosures: Calabrese reports he is a consultant for AbbVie, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Janssen, Pfizer and Sanofi; and is on the speakers bureau for AbbVie, Bristol-Myers Squibb, Crescendo Bioscience and Genentech. Hanauer receives consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Hospira, Janssen, Merck, Pfizer, Samsung, Takeda and UCB.