by Belén Diego

MADRID, Oct 3 (APM) - Sol Ruiz, chair of EMA's Biologics Working Party (BMP), has said bioequivalence studies guarantee that the safety and efficacy of biosimilars equals those of originators, but physicians, regulators and patients need to be on board to use them.

Speaking at the session "Shaping the biosimilars opportunity" at biotech association Asebio's annual meeting in Bilbao late last week, Ruiz said that as their clinical use expands, knowledge about biosimilars becomes increasingly consolidated, with the solid backup from pharmacokinetic (PK), safety and efficacy data, plus the pharmacodynamics (PD) data which is recommended in some cases.

Questioned by APM, she said these scientific data would support automatic biosimilar substitution, as has been discussed in Italy (APMMA 47734), but this is not the ideal way to go. "This must not be an imposition. The co-operation of all stakeholders is certainly needed," she added.

She said clinicians are used to reading clinical trials, whereas PK and PD studies are not necessarily their area of expertise. "These kind of data are not easy to interpret," she noted.

According to Ruiz, an increasing number of physicians are trusting EMA's guidelines for biosimilar use. She said: "Even though they may not completely understand the molecular characterisation of a biosimilar medicine, they trust the system".

Ruiz clarified that this is easier with molecules whose mechanisms of action are better known, such as insulin, filgastrim or erythropoietin, than with monoclonal antibiodies or certain rheumatology drugs. She noted there are uncertainties to address regarding those less known drugs, so some kind of "bridging studies" might be be useful in that scenario. "It is something we are getting to learn by experience and we are willing to discuss," she added.

With Europe ahead of the U.S. regarding approval and use of biosimilars, Ruiz said she has seen a number of improvements regarding knowledge about and management of biosimilars over the EU's 10 years of experience. She said biosimilars are not seen as mere copies any more but as similar medicines which perform like the originators.

Esteban Corley, founder and director of biotech firm mAbxience Argentina and also a speaker, emphasised that the role of biosimilars is to improve drug access.

Corley said the price of a biological cancer drug dropped from $423 to $129 when its biosimilar was approved in Argentina. "However, sales in units did not drop. Instead, we saw an increase in the number of patients who were treated with this innovative, effective drug, and that is an important goal," he said.

He added that although the government had expected to curb the drug spend with the arrival of this biosimilar, that had not been the case. However, they got to treat a lot more people with the same amount of public expenditure, while at the same time sales of the originator drug had continued to increase, he noted.

He noted that biosimilar manufacturers do not only follow regulators' mandate regarding bioequivalence studies but thoroughly analyse the product they develop because it is their responsibility towards their company and the public.

Regarding bioequivalence, he said: "If it walks like a duck, swims like a duck and quacks like a duck, maybe we should leave distrust behind and admit it is a duck indeed". According to him, this approach will help the sustainability of healthcare systems and improve drug access.

/bd/clg