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Pegfilgrastim Next As Fresenius Kabi Eyes Five Biosimilars In 2025

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).

Biosimilars Sales & Earnings

Coronavirus Spotlight


OUTLOOK 2021

In Vivo’s annual showcase of special features and industry league tables for pharma, medtech and generics companies


VIEW 2021 RANKINGS

International Health Partners Urges Integrated Approach To Donations And CSR

Generics firms are increasingly adopting a more integrated approach to corporate social responsibility activities, including product donations, as part of their strategy as they work alongside organizations such as International Health Partners, the charity’s CEO Adele Paterson tells Generics Bulletin.

Generic Drugs International NGO Action

Neuraxpharm CEO Confirms Expansion Into New Markets, Including US

In an exclusive interview with Generics Bulletin, Neuraxpharm CEO Jörg-Thomas Dierks reveals that the company plans to expand out of Europe into other markets by acquiring companies in regions such as the US.

Strategy Leadership Value-Added Medicines
 

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Pegfilgrastim Next As Fresenius Kabi Eyes Five Biosimilars In 2025

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).

Biosimilars Sales & Earnings

Aspen Expects Growth Following Sandoz And Viatris Deals

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.

Sales & Earnings Deals

Phlow Partners With USP On Continuous Manufacturing

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.

Deals Manufacturing

Nippon Chemiphar Is Managing To Slow Its Decline

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. 

Generic Drugs Sales & Earnings

Canada’s CGPA Installs New Leaders

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

Appointments Leadership

Viatris Share Price Plunges Amid Weak 2021 Financial Guidance

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.

Sales & Earnings Commercial
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Policy & Regulation Explore this Topic

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Time Is Ripe For Global Action On Orphan Biosimilars

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

Biosimilars Regulation

EU Industry Renews Call For Digital Regulatory Infrastructure

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.”

Regulation Europe

Complex Generics: US FDA, Sponsors View Roadblocks Very Differently

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.

Generic Drugs User Fees

FTC Makes Double Reverse Payment Case Against Endo And Impax

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.

Legal Issues Generic Drugs

Global Regulators Issue Advice On Clinical Comparability Of Biosimilar MAbs

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

Biosimilars Regulation

UK’s CMA Drops Part Of Prochlorperazine Probe

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.

Regulation Legal Issues
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Generic Drugs Explore this Topic

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Nippon Chemiphar Is Managing To Slow Its Decline

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. 

Generic Drugs Sales & Earnings

US Start-Up Phlow Receives Further Capital Injection To Fund Essential Medicines

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.

Coronavirus COVID-19 Manufacturing

FDA’s OGD Takes Fight To COVID-19 With Half-Century Of Approvals

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.

FDA Approvals
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Biosimilars Explore this Topic

Set Alert for Biosimilars

Time Is Ripe For Global Action On Orphan Biosimilars

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

Biosimilars Regulation

Pegfilgrastim Next As Fresenius Kabi Eyes Five Biosimilars In 2025

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).

Biosimilars Sales & Earnings

Five Competitors Confirmed On Canadian Adalimumab

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

Biosimilars Launches
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Value-Added Medicines Explore this Topic

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Three Pillars Must Support Value Added Medicines In EU

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.

Value-Added Medicines Europe

Glenmark’s Ryaltris Close To Entry In Major Eastern Europe Market

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.

Approvals Value-Added Medicines

Industry Calls For Changes To Maximize Benefits Of Off-Patent Oncology Drugs

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.”

Europe Policy & Regulation
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