Challenges Exist in Implementing Biosimilars for Rheumatoid Conditions

The development of biosimilars has created much interest as an alternative treatment to costly biologic drugs for patients with rheumatoid conditions among other diseases.

Biosimilars have the ability to reduce costs, and increase access to medication, but challenges exist regarding various aspects of developing and marketing the drugs.

Different opportunities and challenges regarding biosimilars will be discussed during the Emerging Biosimilars in Therapeutic Management: Where We Are and What Is in the Future session at the American College of Rheumatology and Association of Rheumatology Health Professionals annual meeting.

“Biosimilars represent a growing market that is still facing some major difficulties,” said Candida Fratazzi, MD, the president of BBCR Consulting, who will be speaking during the session.

Regulating the production of biosimilars is the largest challenge experienced when manufacturing the drugs. Verifying that the safety and efficacy is comparable to the reference product has become a challenge for regulatory agencies across the world.

“Currently, interchangeability is a unique prerogative of the US Food and Drug Administration,” Dr Fratazzi said. “Indeed, the European Medicines Agency cannot mandate interchangeability.”

In Europe, determining interchangeability is determined by each country, and not through the regulatory agency.

The quality of monoclonal antibodies, biotherapeutic proteins, and other agents relies on process- and product-related impurities, which reinforces the need to create stringent standards and regulations, according to the session.

“Some countries in the European Union such as the United Kingdom and the Netherlands have invested resources for the validation of biosimilars in the marketplace by promoting clinical studies designed to answer physicians’ and patients’ uneasiness” Dr Fratazzi said. “Immunogenicity is an element of uncertainty that can only be assessed in clinical trials.”

However, preclinical testing can typically provide the risks associated with each biosimilar under investigation.

Another challenge to overcome is the adoption of the drug, and that some individuals may be uneasy about using biosimilars. Surveys have indicated that patients are generally unaware of biosimilars, but as information increased, their interchangeability was better understood.

A survey conducted in the European Union indicated that 31% of respondents were fully confident in using biosimilars even if their physician explained the drug to them.

Overcoming these challenges is important since biosimilars offer significant advantages, according to the session. The session will also cover recent commercialization of the drugs, and perspectives from payers and physicians about biosimilars.

“Patients can gain major benefit from biosimilars adoption,” Dr Fratazzi said. “Biologics are often used for long-term treatment and their high cost could represent a major limitation.”