Tough EU biosimilar regulation designed to protect industry, says Commission
The EU insisted on tough regulation for biosimilars to ensure the industry was not killed off in its infancy as it sought to reduce the risk of a potentially dangerous copy coming onto the market, said Nicolas Rossignol, a senior pharma administrator for the European Commission's Enterprise and Industry Directorate-General.
The EU insisted on tough regulation for biosimilars to ensure the industry was not killed off in its infancy as it sought to reduce the risk of a potentially dangerous copy coming onto the market, said Nicolas Rossignol, a senior pharma administrator for the European Commission's Enterprise and Industry Directorate-General.
Addressing the recent European Generics Associations' biosimilar symposium in London, he said the immediate tough regulation was at least partly driven by a "political perspective" that demanded that no sub-standard biosimilar product made it to market.
Rossignol said the Commission has a "policy objective of a safe system" to protect the industry because if "the system crashes that would kill development of the sector." He said this explained why the amount of data on biosimilars required in the EU is relatively high.
He added that as the sector developed the data demands might fall. However, this was certainly not guaranteed and biosimilars needed to continue to show the highest standards of safety.
The biosimiliar industry has said it sees its future in producing top-quality therapies and the EGA sees the word "biosimilar" as a marker for that. However, because of the highly complex nature of the biologic sector - especially biosimilars - the World Health Organisation has stepped in to formulate procedures for the regulation of copies of biologicals for some countries that will be unable to do so themselves.
The WHO is now at a critical stage in development, with top-level meetings of international biosimilar experts from the EMEA and elsewhere lined up for later this year. However, while much of the WHO's work to regulate biosimilars has gained EU support, it is developing a two-pronged approach to approving biological copies, which is raising concerns.
The WHO is using the term subsequent entry biological (SEB) for biological copies and is looking at two regulatory approaches. The "biosimilar" approach, which demands comparability tests to show biosimilarity to the reference product, gained support at the EGA meeting.
However, concerns were expressed over the "stand alone" approach, which does not seek proof of quality, safety and efficacy to the reference product in the same way that Europe and others are looking for. Rossignol said such an approach could give the impression of double standards for biosimilars and could have a negative effect on the whole industry.