Biosimilar medicines have the potential to foster unprecedented access to several vital biologics – used to treat serious diseases such as rheumatoid arthritis and cancer - coming off patent by the end of the decade. Recent studies show considerable variations in policy across the EU, translating into heterogeneous uptake of biosimilars in EU Member States. To foster greater equity in access to these life-changing therapies, three key enablers are needed: trust in biosimilars, sustainable market policies, and predictable legal and regulatory environments.

We continue to see concerns being raised about biosimilars among patients and health professionals, even though these products have generated over 400 million patient days of safe clinical experience over the last ten years. Building trust in biosimilar medicines will require active dialogue, and regulators play a key role in conveying the scientific principles that support the medicines review and authorisation process. It is critical that these principles are consistently translated into national policy and positions of professional and patient societies.

Biosimilar development and manufacturing require significant investment. A sustainable and well-functioning biosimilar market must allow for sufficient competition among manufacturers to achieve a price-volume combination that enables both access and continuous investment in R&D. Experience in the EU points to a need for access policies that include procurement as one component of a broader scheme, in which tangible benefits are considered for all stakeholders.

The EU's legal and regulatory frameworks have been validated through ten years of clinical experience with 20 biosimilar products. Now, other countries have developed biosimilar pathways and products are becoming available. It is important that EU regulators actively engage in international dialogue so that the evolution of the regulatory science and frameworks for biosimilar medicines is based on real world evidence and provides companies with a reasonable level of certainty and predictability. 

The Biosimilar Medicines Group is actively engaged in supporting the sector to deliver on its promise through education and scientific exchange. The Group collaborates with regulators, HCPs, patients, payers and policy makers to ensure that the coming wave of patent expiries leads to dramatic increases in patient access and improved healthcare system sustainability.
 

Carol Lynch

Carol Lynch is the Global Head of Biopharmaceuticals at Sandoz and Chair of the Biosimilar Medicines Group, a Medicines for Europe sector group. With more than 25 years of global pharmaceutical and generics industry experience, she leads a 3,000+ person organisation focused on the development, manufacturing and commercialisation of biosimilars. Prior to joining Sandoz, Lynch held several global and country-level Commercial and Development leadership positions in Novartis Pharmaceuticals.