The battle over biologic drugs in the country has taken an interesting turn following the latest interim order from the Delhi High Court involving Roche’s breast cancer drug Trastuzumab sold under the brand name Herceptin.

In its 227 page order, the Court has allowed companies like Biocon, Mylan and Reliance Life Sciences to sell their versions of the biological breast cancer drug Trastuzumab, but disallowed them from claiming it is a bio-similar version of Roche’s Herceptin.

The defendants (Biocon, Mylan and Reliance Lifesciences) may continue to manufacture, market and advertise their product under the name CANMAb or Bmab-200 or Hertraz on the basis of the approvals already granted to them, without calling their products as “bio similar” and/ or “bio-similar to Herceptin, Herclon, Biceltis” or in any way ascribing any bio-similarity with Herceptin, the order said.

Further, it added that the defendants could manufacture and market the drug as Biocon's Trastuzumab or Mylan's Trastuzumab to describe the composition of the molecule. And this could be mentioned on the product and on the product insert (found in the pack), but not in a prominent manner.

The order is a first of sorts as it paves the way for greater clarity on the regulatory pathway for bio-similar products, said Pratibha Singh, a senior counsel for Biocon and Reliance Life Sciences.

Unlike allopathic medicines where a generic version has chemically similar properties, bio-similars present a far more slippery slope. They are “highly similar” versions of an approved biological drug. And the tricky part is that they are complex, sensitive and way more difficult to make. Pricing of these products make the terrain more difficult, with bio-similars being priced less that the innovator drug.

Referring to a key point of contention between Roche and the companies making versions of Trastuzumab, the order said, the use of data by the generic companies in the product insert without undergoing the entire process of the trials was misleading. As a result they were restrained from using the data relating to manufacturing process, safety, efficacy and tests conducted for the safety of the drugs, till a final decision on the issue of bio similarity was made in the present suit.

The order nevertheless kept the door open for generic companies to claim bio-similarity, provided they furnished fresh data inline with the 2012 guidelines on biosimilars.

Reacting to the order, Roche said: “The court has made clear that the approvals granted to these companies are not in accordance with the existing protocol for biosimilars and, therefore, their drugs cannot be considered biosimilars.”

The Swiss drumaker added that it took a legal recourse as the holder of the Herceptin trademark and innovator of Trastuzumab to ensure that a product claiming to be a bio-similar of Trastuzumab actually satisfied the criteria for a bio-similar. “Today’s ruling sends a strong, positive signal that the development, manufacture and approval of bio-similars in India must be subject to rigorous clinical and regulatory standards as per the applicable law,” it said,

Biocon clarified that the judgement did not restrict the sale and manufacture of its Trastuzumab, which was in the interest of patients. “We understand it has some observations with respect to packaging and labelling, which we will address appropriately. Our Trastuzumab, CANMAb™ has undergone all applicable comparability studies,” a company spokesperson said, adding that they had just received the interim order and would examine all options.

With the different companies and patient groups still digesting the implications of the order, breast cancer patients can breathe a little easy as they will continue to have a choice on this drug in the market.

jyothi.datta@thehindu.co.in

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