The tough road ahead for Biosimilars or follow-on-biologics

I may call it a coincidence...that on women’s day I am posting this blog about a drug on breast cancer. I was just assessing the regulatory perception of the news and its relevance to the women in India...oh but before that let’s get to the core news.

On 5 February, Delhi high court restricted Biocon and Mylan from claiming similarity to the Roche breast cancer drug HERCEPTIN® in India.

The new biosimilar product was to be launched under the trade name Hertraz by Mylan and as CANMAb by Biocon in early 2014 under co exclusive rights for the product in India.

Biocon and Mylan have challenged Roche’s contention, insisting that the package insert is duly approved by the drug authority. The approval of what is essentially a generic version of the targeted drug came three months after Roche's patent on HERCEPTIN® expired in India.

Significance of the approval was that it was the first biosimilar trastuzumab to be accorded regulatory approval.

Monoclonal antibodies (MABs) currently represent the fastest growing segment within the biopharmaceutical industry. Biosimilar manufacturers face many challenges considering the complicated structure and larger size of MABs. Moreover, this market is dominated by leading players and making market entry a difficult plan for biosimilar manufacturers. Regulatory Authority’s concern about transparency and safety with patients are also likely to be critical in a competitive and dynamic environment.

 In addition to the above challenges currently an issue on International Non-proprietary names (INN’s) is fetching attention on international platform.  Under the WHO's current INN policy, nonglycosylated biosimilar receive the same INN as the reference drug, as they're considered highly similar. But glycosylated biosimilar, considered comparable but distinct, get a suffix – such as alpha or beta – added to the INN.

 Debate is on whether Biosimilars should be treated as unique products with uniquely distinguishable International Non-proprietary names. Generic drug makers that are getting into the market want Biosimilars treated as generics, which means they would have the same INN as the reference product. But companies with extensive experience in developing biologics think distinguishable names are necessary because no two biologics are expected to be identical.

Future of biosimilar of HERCEPTIN® in India is unknown yet, but the importance of the fact that an access to affordable and safe medicines to women in India cannot be ignored.