The Hind Business Line reports that the Drug Regulatory Authority in India is “considering a proposal wherein generic versions of bio drugs, called biosimilars, may be mandated to apply for patents.”
Biopharmaceutical drugs are medicines produced using a living system or genetically modified organism. Compared to traditional chemical medicines, even a minor change in the conditions, formulation or the processes can change the final product drastically.
Biosimilar medicines are supposed to be replicate versions of original biopharmaceutical medicines designed to treat the same diseases as the innovator’s product. However, compared to generic versions of chemistry based medicines, biosimilar medicines are extremely complex.
The report quotes the Director General of the pressure group ‘Organisation of Pharmaceutical Producers of India’ (which counts among its members several “Big” pharma companies like Pfizer, Eli Lily, Roche and GSK, significantly excluding generic biggies like Cipla and DRL) as approving this idea because of “the complexities involved,”
The very nature of a biologic means it is practically impossible for two different manufacturers to produce two identical biopharmaceuticals if identical host expression systems, processes and equivalent technologies are not used. This has to be demonstrated in an extensive comparability programme. Therefore, a generic biopharmaceutical cannot exist.”
A “Government source” however said that a final view is yet to be taken.
According to Mr. Ray only such stringent measures can facilitate the growth of the biogeneric business.
Ha.
Prashant
Pranesh Prakash
The article in the Hind Business Line is clearly a pile of crap… What do patents have to do with determining whether a molecule of biosimilar to an originator.
Patents are for invention that are new and inventive…
The Director General of the ‘Organisation of Pharmaceutical Producers of India’ clearly needs to go off and buy a Dummies Book to Intellectual Property.