Biosimilars are similar to reference biological medicines and must demonstrate no clinically meaningful differences in terms of efficacy, safety, and quality.

In this episode, Dr Salim Benkhalifa, Medical Affairs Lead for Celltrion Healthcare France, discusses the benefits of using biosimilars, how the adoption challenges can be overcome and looks ahead to future innovations in the industry.

The main benefit of using biosimilars is cost savings, Salim explains, noting this can “increase patient access to treatment and allow for investment in innovation.”

Having biosimilars can also help prevent shortage of medication, for example if one pharmaceutical company faces supply chain issues, there is an alternative allowing continuity of access to patients. 

Industry is working to overcome challenges through standardised regulatory guidelines, education campaigns, and improved reimbursement processes”

Salim highlights three main challenges facing biosimilars: regulatory barriers, lack of understanding and procurement challenges.  The industry is working to overcome these challenges through standardised regulatory guidelines, education campaigns, and improved pricing and reimbursement processes.

Discussing the regulatory framework, Salim points out different approaches by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in their assessment of biosimilars. He shares an example of how Celltrion had to follow different pathways for approval of its subcutaneous formulation of biosimilar infliximab in these two markets.  

He also shares how Celltrion’s healthcare professional outreach campaign – launched 10 years after the first monoclonal antibody biosimilar was approved in Europe – is helping to improve awareness. 

“There is still an education [piece] to explain to healthcare providers and to the patient… the importance of biosimilars, why we need biosimilars and to reassure also on their… quality, efficacy and safety,” Salim notes. 

Future innovations…may include expanded therapeutic areas”

Future innovations in the biosimilar space may include expanded therapeutic areas, improved administration methods, and reduced immunogenicity.

“Budget savings remain one of the key objective of payers,” says Salim, noting that innovation of biosimilars can lead to improvements for patients. “Due to technological advances, further innovation in biologic development has resulted in medicines that offer benefit [beyond] those offered by a reference product.”

Developing subcutaneous formulations, for example, can reap benefits for both patients and healthcare systems, giving patients the ability to self-administer at home, rather than travelling to hospital for IV infusions. 

Listen to the full podcast to learn more!

Dr Salim Benkhalifa is Medical Affairs Lead for Celltrion Healthcare France. With university degrees in immunology and IBD, Dr Salim Benkhalifa is a medical doctor with an MBA. He has previous experience at Pfizer, as medical manager at local and international level in rheumatology and IBD, as well as global medical director in dermatology. Dr. Salim Benkhalifa also held a post at Abbvie as Medical affairs lead for France in IBD and Rheumatology.

The post EPR Podcast Episode 21 – Biosimilars – Salim Benkhalifa, Celltrion Healthcare France appeared first on European Pharmaceutical Review.