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Third-Quarter Indian Results Roundup: Alkem, Neuland, JB, Zydus And Natco

Several Indian firms have posted growth in their financial third quarters ended 31 December 2018. Alkem’s International sales manage to offset a slide in its domestic turnover, Neuland picks up momentum despite the impact of raw material price increases, while a better product mix in India works in JB’s favor. Zydus obtains a raft of US product approvals and lays out its approach for generics and biosimilars across the globe, while Natco focuses on complex generics in Canada and Brazil.

India Companies Sales & Earnings

E-Leaflets Could Benefit Both European Patients And Industry

By facilitating stock movements by enabling patients to access local-language product information digitally, plans to implement e-leaflets in Europe could also help to alleviate product shortages, the president of Medicines for Europe has suggested.

Europe Regulation Drug Safety

Sun Pharma Commits To Generic Investment But Admits It Is Not Attractive In Current Environment

Sun’s MD Dilip Shanghvi made the rather frank admission during the firm’s third-quarter earnings call, maintaining that generics is nevertheless an “interesting” business for the Indian major. In light of this outlook, Sun has continued its policy of withdrawing what it feels are “unviable” ANDAs from under FDA review.

Strategy Generic Drugs Sales & Earnings
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How to Drive Consistent and Long-Term Growth In the Off-Patent Pharma Arena

Read this new report which provides highlights from senior voices in the pharmaceutical and financial industry who participated in a roundtable in November at the House of Lords. Topics discussed include Brexit, moving up the value chain and much more.

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Commercial Explore this Topic

Glenmark Plans To Spin Out A US-Based ‘Innovation’ Business – And May Pull The Plug On Advair

Having amassed a significant pipeline of innovative assets, India’s Glenmark has made the choice to spin them off into a new company that will be housed in the US. 
Strategy Biosimilars

Neuraxpharm Strengthens French Business By Appointing Brun As General Manager

European CNS specialist Neuraxpharm is set to enhance its position in the French market by appointing Pierre-Hervé Brun as general manager of its French affiliate. The firm has also strengthened its international identity by rebranding its Spanish subsidiary Qualigen to Neuraxpharm Spain.

France Appointments

Gedeon Richter Predicts Two-Year Wait To Refile Pegfilgrastim, But Teriparatide Is In The Wings

A timeline to refile, for a second time, its proposed biosimilar to Neulasta with the EMA and plans to launch its biosimilar to Eli Lilly’s Forsteo across the EU featured on Gedeon Richter’s full-year earnings call for 2018.

Biosimilars Review Pathway

Bangladesh’s Beximco Sees Exports Boom As It Expands in North America

Shipping a fourth product to the US, as well as two launches in Canada, ensured exports accounted for more than a tenth of Bangladeshi producer Beximco’s half-year turnover.
Bangladesh United States

Indivior Sets Out Next Steps As It Braces For Suboxone Rivals

Indivior is exhausting all its options to try and stop the impending launch of US generic rivals to Suboxone from 19 February, including petitioning the country’s Supreme Court to intervene. But even if Dr Reddy’s and Alvogen do launch their versions next week, the originator is planning to combat them with an authorized generic.

United States Generic Drugs

ANDA Litigants Join Forces To Cut Costs And Cope With Competition

Generics firms challenging patents in the US are seeing benefits through teaming up, according to Kent Walker of Brinks Gilson & Lione.

United States Intellectual Property
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Policy & Regulation Explore this Topic

FDA Guides On Pathway For Competitive Generic Therapies

Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s latest move to advance generic drug competition.

FDA Generic Drugs

Australia Pushes For Harmonization As ICH Paper Provides Framework

Planned regulatory reforms in Australia would align requirements for generic applications to global standards as well as incentivize filings for complex generics.
Australia Generic Drugs

Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise

A deal on the European SPC manufacturing waiver has been agreed by the European Council, Parliament and Commission, providing a concrete path for a Regulation to move forward, albeit with compromises on several key provisions. Meanwhile, the European off-patent and brand industries remain at odds over the benefits of the waiver.

Europe Intellectual Property

Abilify And Vimpat Rivals Join France's Répertoire

Generic versions of brands such as Abilify, Flixotide, Sprycel and Vimpat have been added to France’s répertoire of generic equivalents by local medicines agency ANSM.

France Generic Drugs

CHMP Knocks Back TLC’s Doxorubicin Hybrid

As the CHMP refuses to recommend granting approval for TLC’s doxorubicin hybrid, the committee within the EMA has given the nod to Teva’s Ajovy monoclonal antibody migraine remedy as well as two small-molecule generics from Krka.

Europe Regulation

Fresenius Nod In EU Adds To Crowded Adalimumab Market

Fresenius Kabi has become the latest firm to receive a nod for a European biosimilar rival to Humira, adding to an already crowded biosimilar adalimumab market.

Europe Biosimilars
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Latest From Generic Drugs

Glenmark Plans To Spin Out A US-Based ‘Innovation’ Business – And May Pull The Plug On Advair

Having amassed a significant pipeline of innovative assets, India’s Glenmark has made the choice to spin them off into a new company that will be housed in the US. 
Strategy Biosimilars

FDA Guides On Pathway For Competitive Generic Therapies

Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s latest move to advance generic drug competition.

FDA Generic Drugs

Australia Pushes For Harmonization As ICH Paper Provides Framework

Planned regulatory reforms in Australia would align requirements for generic applications to global standards as well as incentivize filings for complex generics.
Australia Generic Drugs
See All

Latest From Biosimilars

Glenmark Plans To Spin Out A US-Based ‘Innovation’ Business – And May Pull The Plug On Advair

Having amassed a significant pipeline of innovative assets, India’s Glenmark has made the choice to spin them off into a new company that will be housed in the US. 
Strategy Biosimilars

Gedeon Richter Predicts Two-Year Wait To Refile Pegfilgrastim, But Teriparatide Is In The Wings

A timeline to refile, for a second time, its proposed biosimilar to Neulasta with the EMA and plans to launch its biosimilar to Eli Lilly’s Forsteo across the EU featured on Gedeon Richter’s full-year earnings call for 2018.

Biosimilars Review Pathway

Amgevita Launch In Finland Is No Counterbalance For Remsima Loss, Orion Anticipates

Intensified competition and declining prices, coupled with a failure to scoop winner-takes-all tenders in certain Nordic markets, took a huge bite out of Orion’s biosimilars sales in 2018. Launching the first Humira biosimilar in Finland will not plug the gap, the company has stated.

Biosimilars Europe
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Latest From Value-Added Medicines

CHMP Knocks Back TLC’s Doxorubicin Hybrid

As the CHMP refuses to recommend granting approval for TLC’s doxorubicin hybrid, the committee within the EMA has given the nod to Teva’s Ajovy monoclonal antibody migraine remedy as well as two small-molecule generics from Krka.

Europe Regulation

Basaglar Follow-On Insulin Booms For Eli Lilly

Lilly’s Basaglar insulin glargine hybrid is well on its way to becoming a billion-dollar blockbuster.
Metabolic Disorders Sales & Earnings

Amneal’s Stewart Chairs AAM Board

Amneal president Bob Stewart has been announced as chairman of the US Association for Accessible Medicines, alongside a raft of other appointments, as the AAM holds its annual meeting in New Orleans.

United States Generic Drugs
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