Biosimilars are products that attempt to replicate biologics – medicines which involve living organisms – and are similar, but not identical to, the innovator drug. Like their pharmaceutical counterparts, they are offered at discounted prices to patients.
But because biosimilars are based on biologics, which are more complex than the small molecule chemical drugs copied by generic pharmaceutical companies, it is not yet possible to make them identical to the reference product, and this has made it necessary for regulators to develop alternative approval processes than those used for traditional generic drugs.
The EU was the first to issue guidelines on biosimilars in 2005. To date, the European Medicines Agency (EMEA) has approved 11 biosimilar products and issued positive opinions on four more. These include Omnitrope (somatropin), the follow-on to Pfizer’s Genotropin, which is a recombinant human growth hormone product used to treat children and adults with growth hormone deficiency. It was the first biosimilar to be authorised by the EMEA in 2006.
John Purves of the EMEA, who spoke yesterday at another session on EU developments in biotechnology, told Managing IP that the European Commission and the EMEA worked closely with all of the interested parties and remained focused on the neutral ground of science in order to develop the guidelines.
The US has been slower to look at biosimilars, although there are several bills pending on the issue. In June 2007, the Senate Committee on Health, Education, Labor and Pensions voted in favour of a biosimilars bill, but it was never reported. However, Richard Kingham of Covington & Burling, who provided a legal overview on biosimilars during yesterday’s session, said that there could be US legislative action this year.
Kingham also said that both Canada and the World Health Organization have issued draft guidelines on biosimilars.
Friedrich Nachtmann of Sandoz,
which has been active in the biosimilars market, encouraged the
audience to support the industry and emphasized the need for US action.
“We need the same regulatory standards applied to all biologics,” he
said. “The regulatory requirements must evolve.”
Craig Wheeler of Momenta Pharmaceuticals added: “What we do in the US has the ability to create the industry or destroy it in its infancy.” Wheeler also said that improvements in technology will soon make it possible to manufacture exact replicas of biologics, which would considerably change the debate.
Stephen Juelsgaard of Genentech voiced his concern about biosimilars potentially discouraging innovator biopharmaceutical companies from investing in research and development.
Juelsgaard said that, since the risk, length and cost of biopharmaceutical innovation is significantly higher than in other industries, the data exclusivity period for biopharmaceuticals must be increased in the face of a growing market for biosimilar products. He said: “We need to strike the right balance. There is clearly a need for lower cost medicines, but we can’t fundamentally undercut innovation.”
