Fresenius Kabi has drawn up a roadmap to offering five biosimilar products by 2025, with a biosimilar to Amgen’s Neulasta (pegfilgrastim) set to rival competitors in the US and Europe later this year, ahead of a biosimilar to Roche and Chugai’s Actemra/Ro-Actemra (tocilizumab).

Aspen expects to report significant growth in its continuing operations for the first half of its financial year, following deals with Sandoz and Viatris that have seen the South African firm divest major businesses in Japan and Europe.

Phlow Corp has announced a strategic alliance with the US Pharmacopeia to certify and validate continuous manufacturing processes as it aims to bolster US supplies of essential medicines. The company believes the move could serve as a catalyst for wider generics industry adoption of continuous manufacturing.

Japan’s Nippon Chemiphar has managed to reduce its rate of decline in pharmaceutical sales in the third quarter of FY21, on the back of well-performing recently-launched generics and group-wide structural reforms and cost reductions. The company is making no changes to its full-year forecast. 

Canada’s off-patent industry association has looked to Pharmascience and Apotex for its new chair and vice-chair.

Viatris’ share price closed the day nearly 15% down after announcing weaker than anticipated revenue, adjusted EBITDA and cash flow guidance for 2021. The market reacted strongly to the company’s expectations and ambitions, with management continuing to stress the strength of the combined Mylan and Upjohn businesses.

European industry association wants global convergence on development requirements, though the European Medicines Agency says that this would prove challenging.

Medicines for Europe has renewed its call for a modern digital regulatory infrastructure in the wake of the COVID-19 pandemic to bolster communication and preparedness for future health crises, insisting that there is “no further excuse to delay.”

As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.

The generics firm essentially paid the brand to keep its product off the market, FTC alleges in case about Opana ER litigation. Endo considered bringing back its original formulation of oxymorphone but instead reached agreement with Impax to share profits of its generic, antitrust suit claims.

The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.

The UK’s Competition and Markets Authority has closed “on administrative priorities grounds” its investigation into individual agreements between Alliance Pharmaceuticals, Focus Pharmaceuticals, Medreich and Lexon UK over the supply of prochlorperazine. However, an allegedly anti-competitive “overarching agreement” will continue to be investigated.

Japan’s Nippon Chemiphar has managed to reduce its rate of decline in pharmaceutical sales in the third quarter of FY21, on the back of well-performing recently-launched generics and group-wide structural reforms and cost reductions. The company is making no changes to its full-year forecast. 

Fresh from its $812m government contract to help prevent shortages of essential medicines and shield the US market from global competition, domestic start-up Phlow Corporation has received further financial backing.

The sixth annual report of the FDA’s Office of Generic Drugs covered a year dominated by the novel coronavirus pandemic – although first-time generic approvals and record levels of communication also featured prominently.

European industry association wants global convergence on development requirements, though the European Medicines Agency says that this would prove challenging.

Fresenius Kabi has drawn up a roadmap to offering five biosimilar products by 2025, with a biosimilar to Amgen’s Neulasta (pegfilgrastim) set to rival competitors in the US and Europe later this year, ahead of a biosimilar to Roche and Chugai’s Actemra/Ro-Actemra (tocilizumab).

Multiple competitors have now confirmed the launch of Canadian biosimilar versions of the world’s biggest-selling drug, Humira.

Medicines for Europe has called for fresh efforts to bolster the value added medicines sector and “level the playing field” with the US and its 505(b)(2) pathway, launching a new report setting out the three key areas in which greater EU action is needed.

Having divested a basket of allergy treatments in Russia and the CIS to Dr Reddy’s last year, Glenmark is gearing up to launch its novel Ryaltris nasal spray in a major Eastern Europe market.

Medicines for Europe has made a series of recommendations to improve the contribution of generics, biosimilars and value-added medicines to the European Commission’s “Beating Cancer Plan.” The association has offered a checklist of key policies to “ensure equity and quality of cancer care is achieved.”