FDA disapproves Novartis’s Biosimilar drug, Roche’s fears alleviated
Category: #health  By Dhananjay Punekar  Date: 2018-05-04
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FDA disapproves Novartis’s Biosimilar drug, Roche’s fears alleviated

Roche AG, a Switzerland based healthcare organization, seems to have breathed a sigh of relief with the FDA refusing to grant immediate approval to Novartis’s biosimilar form of Rituxan. According to Novartis’s Sandoz Unit, its copy of Rituxan – the biosimilar medicine used for treating blood cancers has received a complete response letter from the U.S. regulators. Seemingly this is the second case of FDA disapproving the cheaper versions of biotech cancer medicines.

For the record, last month, the FDA had disapproved Rituxan’s biosimilars manufactured jointly by Teva & Celltrion. FDA’s decision, say experts, is certain to boost Roche’s business across the U.S. pharmaceutical market. Indeed, as per statistics, Roche earns nearly USD 4 billion from the sales of Rituxan across the U.S.

Analysts claim that Roche could have incurred a loss of nearly USD 150 million in 2018 across the U.S. if the biosimilar versions of the brand would have been approved by the U.S. FDA.

Incidentally, biosimilar copies of Rituxan have received a green signal from the European regulatory bodies, where the biosimilars manufactured by both Novartis & Celltrion are easily available. It has been claimed that the easy access of Rituximab’s biosimilars in Europe are cutting down the profits of Roche in the region. Reportedly, the sales of Rituximab, a brand of Rituxan, had dipped by nearly 44% in Europe during the first quarter of 2018.

As per authentic sources, the tough competition observed across the biosimilars industry & the stringent focus of investors to pour in capital in the firms manufacturing biosimilar medicines has threatened the sales prospects of the original drug manufacturers such as AbbVie and Roche AG.

For the record, Sandoz mentioned that it is currently in the process of evaluating FDA’s response letter and will stand strong behind the evidence that the regulatory submission has included for its biosimilar.



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Dhananjay Punekar

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Dhananjay Punekar

Dhananjay Punekar presently develops content for a slew of portals, including Market Size Forecasters and Algosonline. A post graduate in mathematics and business administration, he worked in Infosys BPO Limited prior to switching his professional genre. As a content wr...

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