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Manufacturing

Set Alert for Manufacturing

Coherus Plots ‘Lowest Price Adalimumab’ With Huge Discount, Ties Up With Mark Cuban

Coherus BioSciences had teased a “compelling value proposition” for its Yusimry (adalimumab-aqvh) biosimilar to AbbVie’s Humira blockbuster and it has delivered, with a pair of pricing strategies include one though an alliance with self-labelled “disruptor” Mark Cuban.

Biosimilars Pricing Strategies

Teva: Our Biosimilars Strategy Has Been Fragmented, We Want To Be Global

Months into the job, Teva CEO Richard Francis delivered the company’s promise for a new dedicated strategy to return to growth. Funded by a portion of capital reallocated from Teva’s generics business to focus on innovative brands, the new strategy will continue to promote biosimilars, Teva has outlined.

Biosimilars Strategy

Cipla's Advair Generic US Debut May Be Pushed Out But 'Value Intact'

Cipla to pursue two-site, de-risked filing approach for large respiratory assets even as it awaits an FDA compliance classification for its Indore facility, which will determine the launch timelines for its much-awaited generic Advair in the US.

Sales & Earnings Strategy

US FDA Doesn’t Want ANDAs With Facilities Not Ready For Inspection Even Though It Can Accept Them

An agency official said the GDUFA III provision hopefully will be used for only a small number of ANDAs. We chart the approval times and first-cycle clearances over the course of the generic user fee program.

Generic Drugs Manufacturing

Neuraxpharm Rebrands Spanish Subsidiary As It Focuses On European Profile

Neuraxpharm has rebranded a Spanish finished dosage form facility to mark its “full integration” within the group, as it focuses on building its profile in Europe.

Strategy Advertising, Marketing & Sales

Sandoz Makes Major Moves To Bolster Biosimilars Ahead Of Spinoff

Sandoz has made further preparations to bolster its biosimilars business ahead of its spinoff from parent company Novartis, announcing a development and manufacturing deal with Evotec at the same time as unveiling a further investment in its Holzkirchen site to transform it into a biotech development hub.

Biosimilars Deals

Olainfarm Sets Out Ambitions With €100m Investment

Latvian firm Olainfarm has set out ambitious plans to “become one of the 10 most important pharmaceutical companies in Europe in the next five years,” in part through investments worth €100m in its portfolio and a manufacturing overhaul.

Strategy Manufacturing

Alvotech’s Latest FDA Knockback Cuts It Fine For Humira Rival

Alvotech has received a further complete response letter from the US FDA relating to its AVT02 proposed adalimumab biosimilar rival to Humira. The latest BsUFA goal date disclosed for the product is now just a few days ahead of a potential US launch.

Biosimilars United States

Mabxience Sets Out Investment Plans Under Fresenius Ownership

Unveiling plans to install a new bioreactor at its Genhelix site in Spain, mAbxience is bolstering its biosimilars manufacturing capabilities and CDMO capacity under the majority ownership of Fresenius Kabi.

Manufacturing Strategy
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