by Thomas Meek at the joint Medicines for Europe and IGBA annual conference in Dubrovnik
DUBROVNIK, June 9 (APM) - The pharma industry needs to address the "distrust" that remains among healthcare professionals regarding biosimilar medicines, according to a senior figure at the European Medicines Agency.
Emer Cooke, head of international affairs at the European drugs regulator, told delegates at a conference that the EMA needs to work more on improving its communication and education efforts to help healthcare stakeholders understand the benefits of biosimilars - equivalent version of biological drugs that have lost patent protection.
"We have been guilty in the past of not appropriately communicating our outcomes in a way that meets the needs of the prescribers and the patients," said Cooke, who was speaking during a panel discussion at a joint meeting of trade bodies Medicines for Europe and the International Generic and Biosimilar Medicine Association (IGBA) in Dubrovnik, Croatia.
Despite these reservations, Europe is one of the regulatory leaders for these products. Since 2006, 24 biosimilar products have been approved in the region, while the EMA was also the first medicines regulator in the world to put in place a specific framework for the regulation of biosimilars, a decade ahead of the U.S.
More can be done though to improve uptake of these medicines, said Cooke, who added that the EMA had invested heavily in its education efforts over the past five or six years, including via the launch of several working groups and an information session that took place in 2015 to discuss biosimilars.
"We are very committed to increasing the uptake of biosimilars and making sure the products that are authorised are of high quality, safety and efficacy and that we can make sure that once they get onto the market they will benefit patients."
This is part of wider efforts from the EMA to build trust across the entire regulatory process for medicines, including improving the transparency of clinical trial data.
Cooke explained that a key area the EMA has learned that stakeholders need more education on is the use of extrapolation of data, which means a biosimilar that has demonstrated equivalence can be approved in all the indications of its originator product even if there are no clinical safety and efficacy data for each indication.
"I think the concept of extrapolation is difficult. You have to try understand it and there is an inherent distrust, I would say," said Cooke.
"We believe studies we are getting allow us to extrapolate. Our job now is to communicate that to people who are going to be using these products."
An important part of building that trust is tracking the use of biosimilar products and seeing how they compare in a real world setting, something that Cooke says can be seen.
"For biosimilars the postmarketing experience is very important and we are very pleased wth the info we get back from biosimilars.
"We have risk management plans for all authorised biosimilars and the evidence shows they can be tracked for the pharmacovigilance system using the batch number and brand name of the biosimilar. And the evidence is they are comparable."
This will be welcomed by the Generic Pharmaceutical Association (GPhA), which has been critical of recommendations from the World Health Organization and the U.S. Food and Drug Administration to introduce a four-character suffix that is unique to each biosimilar in order to identify it from similar products (APMMA 46374 ).
In its arguments the GphA has previously pointed to the European system, which does not use a suffix but still manages to successfully track biosimilar drugs.
/tm/clg
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
