C5 Forum on Biosimilars: the importance of regulation

At the 3rd C5 Forum on Biosimilars in London on Wednesday, a panel of lawyers and regulatory experts discussed the lie of the land for biosimilars.

Biosimilar Medinical Products Working Party vice-chair Martina Weise defined biosimilars as “therapeutic alternatives to their respective products”, though there is not yet a definitive agreed definition.

Manja Epping, a partner at Taylor Wessing LLP, said that “the process defines the product” with biosimilars - they are not like generic versions of small molecule pharmaceuticals.

Frank Landolt, vice president of IP and Legal at Ablynx, said that by 2016, seven of the top 10 drugs will be biologicals, with a market value of $50 billion. Though at the moment, “in some respects, the market is underdeveloped,” he said.

Legislators want to see more innovative drugs entering the market, but also want more generic competition – somewhat contradictory aims, he said.

In order to balance innovation with generic competition, it is necessary to use patent law to protect the innovators, and regulatory rules to encourage generic competition, Landolt added.

“We have to integrate the patent and regulatory fields,” he said, as both can create bars to entry.

The European Medicines Agency has approved 16 biosimilar drugs since 2006.

The EU has been leading in biosimilar development, however, while “biosimilars are a reality in the EU, [elsewhere] they have acceptance problems,” Weise said.

She cited the “biosimilar-but-not-identical” paradigm – by their nature, biosimilars are not identical to their reference products, unlike generic small molecule drugs which share an active ingredient with their innovator counterparts.

This paradigm also presents uncertainty with naming conventions. Generic drugs share their international nonproprietary names (INNs) with their reference products – with biosimilars, this is not the case.

Some countries have suggested the involvement of the INN programme in identifying biosimilars, though Weise said a brand name and lot number for the biosimilars would be sufficient identifiers.

“Unique INNs would contradict the biosimilar concept,” she said, adding that they may be confusing for physicians and patients.

This could present difficulties when seeking a supplementary protection certificate (SPC) for your biosimilar product, Landolt observed. SPCs for small molecules mention the INN name, so what options are available for securing 15 years of effective patent life for biosimilars?

Different regulatory bodies have different views on how much the biosimilar may differ from the chemical structure of the reference product.

“If you want to make a biosimilar that is slightly different, how different can you be?” Landolt said.

“The issue of the INN is huge in terms of the protection you can get.”