• Medicines for Europe and its sector group, the Biosimilar Medicines Group, are celebrating 10 years of positive patient treatment experience and access to better health thanks to biosimilar medicines. Since the first biosimilar medicine was approved and marketed in 2006, EU approved biosimilar medicines have already generated more than 400 million patient days of positive clinical experience accompanied by massively increased access to modern biological medicines.
  • Having established the world’s first regulatory and access model for biosimilar medicines, the EU can develop sophisticated policies for biosimilar medicines to deliver their full potential in terms of access and sustainability of healthcare systems.

Biosimilar medicines provide an opportunity to increase patient access to high quality treatments and to improve the efficiency of healthcare systems worldwide, as demonstrated in the white paper Delivering on the Potential of Biosimilar Medicines: the Role of Functioning Competitive Markets[1]. Over 50 new products in clinical development are expected to increase access to medicines through price competition across Europe and the US through 2020, provided appropriate policy measures in support of biosimilar medicines uptake are put in place, including clear statements by regulatory agencies on interchangeability, more information to patients and prescribers on the benefits and the underlying science of biosimilar medicines and policy incentives for hospitals and prescribers to use more biosimilar medicines. Since their first introduction in the EU, biosimilar medicines increased patient access by 44% in the EU-5 countries between 2006 and 2014[2].

“Biosimilar medicines have the potential to dramatically increase patient access and generate savings for healthcare systems” said Carol Lynch, Global Head of Biopharmaceuticals at Sandoz and Chair of the Biosimilar Medicines Group, a Medicines for Europe sector group. “The Biosimilar Medicines Group is engaged in fostering multi-stakeholder dialogue as an essential means to improving stakeholders’ trust, understanding and acceptance – a critical factor in ensuring uptake for these important products”.

Ahead of the event, Jacek Glinka, President of Medicines for Europe, highlighted that the industry stands ready to work with Member States to increase patient access to biological treatments and reduce health access inequalities across Europe. Glinka called on Member States “to take full advantage of the introduction of biosimilar medicines and devise policies aimed at reducing the disparities in access. Europe has been a leader and an inspiration in setting the scientific framework, let’s continue and have Europe lead in the development of sustainable access policies.”

During the 14th Annual Biosimilar Medicines Group Conference, taking place today and tomorrow in London, the Biosimilar Medicines Group will gather the world’s experts in the field to look back at the 10 year success story of European biosimilar medicines and engage with stakeholders in mapping opportunities for the sector to deliver on the promise of access. Discussions will cover recent market developments and access policies as well as international regulatory convergence and regulatory science, with the involvement of regulators from the EU (EMA and BMWP), US (FDA), Korea (MFSD) and Japan (PMDA).

Biosimilar Medicines Handbook – 3rd Edition

[1] IMS Institute for Healthcare Informatics, March 2016

[2] IMS Midas 2014