by Edouard Hubert at the Pharmaceutiques’ meeting

MARSEILLE, Dec 12 (APM) - Generic's manufacturer Biogaran will launch a biosimilar to Merck Sharp & Dohme anti-TNF Remicade (infliximab) in France in February, company president Pascal Brière said at a round table meeting on generics and biosimilars organised as part of the Pharmaceutiques meeting in Marseille.

In September 2013, the Korean group Celltrion gained the first license in Europe for the biosimilar of a monoclonal antibody (APMMA 35477) and the rights in France are shared between Hospira and Biogaran, the round table heard on Thursday.

At this moment, “the market (for biosimilar Remicade) doesn’t exist,” Brière argued, pointing out that the three existing biosimilars - growth hormone, erythropoietin and haematopoietic growth factor - are “support products” whereas infliximab is “a care product”.

He mentioned the three possible constraints applying to the near copy - the need of secure a viable price, the need for the company to go and see the prescribers - rheumatologists and gastroenterologists - through sales representatives, and finally tight restrictions on what patients these drugs could be prescribed for.

Frances social security funding law (LFSS) for 2014 includes a provision authorising substitution by a biosimilar under particularly supervised conditions. Several industrial sources have reported to APM that the government has told them that it has worked on a draft application decree but it seems no version of the text has circulated yet.

Brière said 2015 would be “a most interesting year” during which it would be necessary to “write the rules” for biosimilars. He acknowledged that knowledge as it currently stands does not allow authorising substitution as is the case with generics and said he believes in “substitution through use” at term. He pointed out that studies are underway on this subject outside France, supervised by the public authorities.

All the round table members - pharmacists, pharma executives and doctors - repeated the fact that they consider it is particularly important to secure patients’ confidence in biosimilars.

Marc-Pascal Lambert, head of central department of pharmaceutical operations for the Marseille group of hospitals (AP-HM) said he would launch a call for tender on Remicade as of February 15 2015. He said the AP-HM central pharmacy is working on “a joint action with the medical profession” in order to accompany the arrival of biosimilars on the market. “A constructive approach is being set up,” he reported.

“We shall not obtain (price cuts) of 83% as for paclitaxel or docetaxel. We shall have between 10% and 20%,” he predicted, warning that AP-HM would choose not to have all the infliximabs at the disposal of the prescribers.

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