Biosimilar development and regulation worldwide is being impacted by the European Union.
What is a biosimilar?
When an approved original biological medicine, or reference medicine’s patent and exclusivity expires, a biosimilar medicine can be developed and submitted for entry in the market. Biosimilars are produced to be highly similar, with some minor differences, to their reference medicine.
The generally accepted definition for biosimilar molecules is: a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference product) that demonstrates similarity to the reference product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise. Ref. Life Science Leader, 7/1/15, “Biosimilar mAbs: Expanding the Global Biosimilar Market” Retrieved from www.lifescienceleader.com
Biosimilars and the EU – The Regulatory Process
Scientific committees within the European Medicines Agency (EMA) are responsible for evaluation and authorisation of biosimilar medicines. Having approved the first biosimilar in 2006 and with 28 recommendations to date, the EU is having a profound effect on biosimilar development and regulation worldwide. Clinical historical evidence shows that biosimilars approved in the EU are as safe and effective as other biological medicines when stored and used properly.
“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” EMA’s executive director, Guido Rasi, said. “Given the role of the healthcare professionals on the front line of patient care, it is vital that they have access to reliable information on these medicines: what they are and how they are developed, approved and monitored.” Ref. European Medicines Agency, 5/5/17, “New guide on biosimilar medicines for healthcare professionals” Retrieved from www.ema.europa.eu
Helpful Information Guide
As a result of the collaborative effort between the EU and EMA, an information guide for healthcare professionals was recently published https://www.scribd.com/document/347919226/EMA-Biosimilar-Guide-for-Healthcare-Professionals#from_embed.
This guide covers the definition and features of biosimilars and why they are not considered generics. Information related to the regulatory and approval process as well as the data for prescribing and EMA assessment is provided. The guide also has a section related to safety, including healthcare professional’s roles regarding the safety profile during clinical use, and points out that approval is based on recommended use as provided in the summary of product characteristics (SmPC) and package leaflet.
With healthcare costs on the rise in many countries, and biologics developed to treat many serious or life threatening diseases being quite expensive, having access to a less costly alternative can be worth investigating. Studies estimate that use of biosimilars results in at least 20 percent price reduction. Incentive programs and strategic models for discount pricing and rebates exist in Germany, Denmark and the Netherlands that have resulted in discounts of nearly 70 percent after market introduction.
After discussing biosimilars with their healthcare professional, patients can expect that biosimilar medicines are a safe and effective alternative treatment option. Like any course of treatment using medicines, biosimilars must be stored and used properly during treatment.
Based on data from the past decade in the EU, approved biosimilars are being produced and administered successfully as a replacement for their reference biologicals. The next decade will see continued patent expirations opening up the opportunity for biosimilars to enter the market, providing a high quality product and a substantial cost savings for physicians, pharmacies and ultimately, the patient.