Short Abstract

The development of a biosimilar medicine in Europe requires a comprehensive product and process development plus comparative testing at quality, non-clinical and clinical level. ‘Biosimilar’ denotes a biological medicine which is highly similar to an already authorised reference biological medicine. These are different from generic products as they are not identical products. This approach ensures that the biosimilar product matches its reference product in terms of quality, efficacy and safety. All EU approved biosimilars products undergo the same rigorous scientific assessment at the European Medicines Agency (EMA) and its committees like any other biological medicine.

Guidance on risk management systems, applicable to all medicines, including biopharmaceuticals, has also been developed which assures safe market entry and post-marketing monitoring of these medicines. Once the medicines are prescribed and dispensed, all European pharmaceutical companies are legally required to monitor their use and effects. They must have systems in place to detect, assess, understand and endeavour to communicate any adverse reactions (sometimes known as “side-effects” ) or any other medicine-related problem. The science and activities of these processes are known as “Pharmacovigilance”. As is the case with every medicine, each manufacturer must submit a Risk Management Plan (RMP) which is a detailed description of the company’s pharmacovigilance system.

This Risk Management Plan (RMP) must be submitted with each new application for marketing authorization (MA) of biosimilar and agreed by the EMA prior to approval of marketing authorisation. The RMP describes what is known about the safety of the medicine and outlines how the manufacturer will further monitor and fill any potential or known gaps in knowledge as well as any measures needed to prevent or minimise any potential risk from the medicine. For many products, the EMA will require additional long-term post-marketing surveillance studies to be conducted in Europe as a condition of drug approval. This plan must be regularly updated throughout the entire time the medicine is marketed and used and is published on the Agency web site. Penalties will result from not completing activities described in this plan.

This webinar will teach you:

• New regulations about completion of RMP’s for biosimilars in Europe
• What is needed in an RMP that you will file to gain MA status in Europe for a biosimilar
• What you need to do before you file your MA application in Europe to ensure the success of your RMP and your MA application