Challenges Ahead for Newly Approved Biosimilar Inflectra

April 8, 2016
Amy Reyes

The U.S. approval of the first biosimilar in rheumatology, Inflectra, has been welcome news. Still, concerns about safety, interchangeability and costs dominate the discussions.

The U.S. Food and Drug Administration’s approval of the biosimilar Inflectra (infliximab-dyyb) was met with great interest from physicians and patient advocacy groups who expressed concerns about safety, interchangeability and costs.

Inflectra (infliximab-dyyb), which is a biosimilar to infliximab (Remicade), was approved on April 5 for patients with moderate to severe rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis, which are the approved indications for Remicade (pediatric ulcerative colitis was excluded due to exclusivity which expires in 2018).

Inflectra’s approval comes after a rigorous review process that included a series of clinical trials in rheumatoid arthritis and ankylosing spondylitis (AS). The trials demonstrated that it was a safe and effective biosimilar to Remicade. However, the FDA was quick to highlight that it was not approved as an interchangeable product and instead, is merely an option that could potentially expand access to treatment for patients.

“Biosimilars can provide access to important treatment options for patients who need them,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, in a written statement. “Patients and the healthcare community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”

The American College of Rheumatology (ACR) applauded the decision citing a potential cost savings for patients, but they also expressed concerns over the need for distinct names and transparent labeling for all biosimilar products to ensure correct prescribing and dispensing, post-marketing surveillance, prescriber confidence and enhanced market uptake.

“The ACR welcomes the introduction of biosimilars to the U.S. healthcare system and is hopeful that the decrease in cost resulting from the availability of safe and effective biosimilars in the U.S. will increase our patients’ access to life-changing therapies and improve their overall health,” the ACR said in a written statement.

Maximizing clarity in labeling, specifically with respect to interchangeability and origins (reference drug versus biosimilar) of clinical data, were concerns expressed by a number of advocacy groups.

Biosimilar naming continues to remain a concern, the ACR said.

“Physicians must be able to confidently prescribe these therapies to patients and know that proper mechanisms are in place to allow rheumatologists to monitor patients’ responses and reactions to biosimilars," ACR president Joan M. Von Feldt, MD, MSEd, wrote in a statement.

Patients for Biologics Safety and Access (PBSA), a coalition of 23 national patient advocacy organizations, expressed concerns that Inflectra was approved in the absence of critical safety policies.

The FDA has issued a draft guidance recommending that biosimilar labeling clearly differentiate biosimilars from their reference product.

“To date, and contrary to its own policy of transparency, the FDA has not issued final guidance on a range of key issues that will impact patient safety including interchangeability, product labeling and naming and approval relying on indication extrapolation. Transparency is essential to build patient confidence in this new category of drugs and patient confidence is crucial to the future success of biosimilars. It is vital that the FDA have a transparent process so patients and the public have an opportunity to review and comment on standards before they are adopted,” PBSA wrote in a statement.

Inflectra, which will be marketed by Pfizer in the U.S., is currently approved for use in 71 countries, but in the U.S., it is new. In fact, it is only the second biosimilar approved in the U.S. The biosimilar Zarxio (filgrastim-sndz) was released in 2015 in the U.S.

“Despite being available in Europe of years, biosimilars remain a new medication class in the United States as the FDA and other stakeholders (manufacturers, physician and patient groups, and payers) continue to debate the process by which biosimilars are clinically evaluated, labeled, and named compared to their reference biologic. Policies regarding approvals, access and payment, directly impact the physician-patient relationship and patient safety,” the advocacy group CreakyJoints wrote in a statement.

It may be some time before Inflectra hits the market in the U.S. Johnson and Johnson, which owns Remicade, issued a statement charging patent infringement if Inflectra is released before September 2018.

“Our patents for Remicade remain valid and enforceable until September 2018. A commercial launch of Celltrion’s infliximab-dyyb in advance of this date would be an infringement of our patents, and we intend to defend our intellectual property rights,” Johnson and Johnson stated. 

Hailed for its cost savings potential, no one can really say how cost will play out in the U.S. Numerous studies have reported that biosimilars have saved as much as 20 to 30 percent over five years for patients receiving CT-P13 for RA in the UK, Italy, France and Germany.

When Novartis released its biosimilar Zarxio (filgrastim-sndz) in 2015, it did so at a 15 percent discount as compared to the cost of the reference product, Neupogen.

Click on the following image to view a slideshow summary on indications, side effects and boxed warnings. 

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