Biocon, My­lan Likely to Ap­peal HC Rul­ing on Roche’s Can­cer Drug

The court or­der im­posed con­di­tions on the drug­mak­ers over sell­ing copies of breast can­cer drug trastuzumab

The Economic Times - - Companies: Pursuit Of Profit - @times­

Vikas Dan­dekar Mum­bai: Mak­ers of biosimilar drugs are un­happy with a Delhi High Court rul­ing that im­posed cer­tain con­di­tions on Biocon and My­lan to sell copies of Roche’s block­buster biotech-based breast can­cer drug, trastuzumab.

The April 25 or­der, which raised ques­tions on the pro­cesses fol­lowed by the In­dian drug con­troller in ap­prov­ing such drugs, could also af­fect the avail­abil­ity and af­ford­abil­ity of an ex­pen­sive can­cer treat­ment, said an in­dus­try ex­ec­u­tive. Based on Roche’s plea, the Delhi High Court in a keenly watched le­gal tus­sle said the ap­provals to Biocon’s brand CANMAb and My­lan’s Her­traz were “not on the ba­sis of the ad­her­ence of the guidelines” and “rules framed un­der the Drug Act.” Roche sells the drug un­der the brand Her­ceptin glob­ally. In In­dia, it is sold as Her­clon and Biceltis.

While sources said Biocon is pre­par­ing for an ap­peal, the com­pany did not com­ment on spe­cific ques­tions ex­cept say­ing it will deal with the is­sue ap­pro­pri­ately. My­lan con­firmed its plans to file an ap­peal to chal­lenge cer­tain lim­i­ta­tions im­posed on the pack­ag­ing and la­belling of its prod­uct. The two com­pa­nies had strongly con­tended that due

A Bit­ter Pill

pro­cesses had been fol­lowed in se­cur­ing the ap­provals for their prod­ucts.

DG Shah, sec­re­tary gen­eral, In­dian Phar­ma­ceu­ti­cal Al­liance strongly, op­posed the court action and said the court has ruled on a mat­ter that drug reg­u­la­tory ex­perts are strug­gling with across the world. “The rul­ing would mean that a biotech prod­uct made by one com­pany in two dif­fer­ent plants is not the same … The drug ap­proval will have to be spe­cific to the man­u­fac­tur­ing lo­ca­tion. Like­wise, a prod­uct made in the lab for ap­proval and then scaled up for com­mer­cial pro­duc­tion is also not the same,” he said.

The or­der had re­strained the biosimilar mak­ers from us­ing data re­lat­ing to the man­u­fac­tur­ing process, safety, ef­fi­cacy and tests till the time a fi­nal de­ci­sion is made on the is­sue of biosim­i­lar­ity. Sid­ing with Roche’s plea, the court noted that the prod­ucts can­not be called a “biosimilar” of Her­ceptin, Her­clon or Biceltis, or in any way as­cribe any biosim­i­lar­ity with that of the in­no­va­tor’s prod­ucts. The or­der also re­quired the biosimilar com­pa­nies to use in­ter­na­tional non-pro­pri­etary name trastuzumab as Biocon’s Trastuzumab or My­lan’s Trastuzumab. The court came down heav­ily on Indi- a’s drug reg­u­la­tory body for ap­prov­ing the prod­ucts. As part of its 227-page de­ci­sion, it said the “process fol­lowed is flawed and suf­fers from the vice of the non-ap­pli­ca­tion of mind and non-ad­her­ence of the statu­tory pro­vi­sions of the Act and Rules as well as Biosimilar Guidelines…” Roche wel­comed the or­der. The com­pany said it is not against biosim­i­lars, but main­tained that it will con­tinue to chal­lenge those that fail to present the data out­lined in the In­dian biosimilar frame­work. “The rul­ing sends a strong, pos­i­tive sig­nal that the de­vel­op­ment, man­u­fac­ture and ap­proval of biosim­i­lars in In­dia must be sub­ject to rig­or­ous clin­i­cal and reg­u­la­tory stan­dards as per the ap­pli­ca­ble law,” it said.

Re­liance Life Sciences, which has also been ap­proved by the In­dian reg­u­la­tor for in­tro­duc­tion of its ver­sions of trastuzumab and has been dragged to the court by Roche, said it has yet to re­ceive a copy of the or­der. The com­pany said it re­ceived in­puts from its lawyers on the op­er­a­tive part of the judg­ment. “There is no im­ped­i­ment on launch­ing of the prod­uct. Re­liance Life Sciences is work­ing on an ap­pro­pri­ate date for the com­mer­cial launch of the prod­uct, within the frame­work of the judg­ment and based on le­gal ad­vice,” it said.

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