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Samsung Bioepis’ Trastuzumab Biosimilar Is Third Cleared By FDA – But The Market Hasn’t Formed Yet

Sued by Herceptin sponsor Genentech for patent infringement, Samsung Bioepis has legal hurdles to navigate before it can roll out its trastuzumab biosimilar in the US, which has just become the third biosimilar of the cancer treatment greenlit by the FDA.

Biosimilars Approvals United States

Aurobindo Acquires Seven Oncology Injectables From Spectrum

In line with its strategy to establish its presence in the US branded market, Aurobindo has through its subsidiary Acrotech Biopharma acquired seven marketed oncology injectables from Spectrum Pharmaceuticals in a deal worth up to US$300 million.

United States M & A Cancer

Korean Court Upholds Rituximab Ruling, Affirming Victory For Celltrion’s Truxima Biosimilar

An obstacle in Celltrion’s path to sell its rituximab biosimilar in Korea has been removed, with a court’s affirmation that a patent covering Genentech/Biogen’s Rituxan original for the use of chronic lymphocytic leukemia is invalid.

Biosimilars Intellectual Property South Korea
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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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European Council Brings SPC Manufacturing Waiver A Step Closer

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

Europe Manufacturing

Manufacturing Roundup – 17 January 2019

Dr Reddy’s is hit with a manufacturing setback after getting issued a Form 483 report for its site in Andhra Pradesh, India, while several firms announce site expansions, including in Spain and the US.

Companies Manufacturing

Industry Veteran Haggar To Lead Private Equity-Backed Zentiva From Next Month

Only four months after it was carved out from Sanofi to become an independent company, Prague-based Zentiva has announced fresh leadership in the form of Nick Haggar, the 30-year industry veteran and former president of Medicines of Europe.

Appointments Europe

Pfizer Axes Staff And Five Pre-Clinical Biosimilars To Fund Late-Stage Innovative Programs

With an eye on moving to market its broad pipeline of innovative brands, Pfizer has cut development of five early-stage biosimilar assets, in a decision that will affect 150 staff. The move is not reflective of Pfizer's overall commitment to biosimilars, the US-based company maintains.

Strategy Biosimilars

Cipla Partners With Bio-Thera For Bevacizumab In Select Emerging Markets

Cipla has formed a licensing agreement with Bio-Thera Solutions for the Chinese firm’s BAT1706 bevacizumab biosimilar, which the Indian company will distribute and sell in select emerging markets.

Biosimilars Deals

Amneal Eyes Generic Injectables Deals, While Competition Bites Sooner Than Anticipated

A strengthened cash position has provided Amneal the chance to seek inorganic opportunities to bolster its growing presence in injectables. The US-based, US-centric company is looking to grow its operations, having been surprised in recent weeks by generic competition to its most lucrative generic assets.

Strategy Pricing Debate
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Policy & Regulation Explore this Topic

Belgium Unveils Incentives For Biosimilar Adalimumab And Etanercept

Belgium has introduced financial incentives to encourage doctors to prescribe anti-TNF biosimilars adalimumab and etanercept outside of hospitals.

Belgium Biosimilars

Wockhardt Wins Review Of Ban On Indian Combination

Evidence put forward by manufacturers to support fixed-dose combinations must be considered by an advisory committee to India’s government, the Delhi High Court has ordered in a verdict favouring Wockhardt.
India Regulation

Remodulin And Revlimid Rivals Join France’s Répertoire

Almost 20 new generic groups – including rivals to Flecaine, Inegy, Remodulin and Revlimid – have been added to France’s répertoire of generic equivalents following the latest update by local medicines agency ANSM.

France Generic Drugs

FTC Grants Teva's Request To Reopen Watson-Actavis Merger

The FTC will allow Teva to continue to supply the Embeda brand to Pfizer in 2019, despite Teva having taken several years to bring its in-development generic version to market.

United States Regulation

Belgian Body Bolsters Awareness Of Biosimilars

Belgian medicines agency AFMPS has launched a public information campaign to educate patients on biologics and to encourage the uptake of biosimilars.

Belgium Regulation

FDA’s Gottlieb Rolls Out A Raft Of Biosimilar Reforms

As the FDA publishes several key guidance documents on biosimilars and biologics, Commissioner Scott Gottlieb has outlined the latest steps in the agency’s ongoing efforts to support the market. These include measures to address the abuse of REMS, as well as transitioning products such as insulin and human growth hormone into the biologics framework.

United States Biosimilars
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Latest From Generic Drugs

First Sabril Rival Sees FDA Deliver On Prioritizing Competition

Prioritizing the approval of generics of medicines with little or no competition has been a key part of the FDA’s efforts to support access and reduce costs to patients; the agency has just granted Teva approval for the first generic version of Lundbeck’s Sabril (vigabatrin) 500mg tablets.

Generic Drugs Approvals

European Council Brings SPC Manufacturing Waiver A Step Closer

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

Europe Manufacturing

Wockhardt Wins Review Of Ban On Indian Combination

Evidence put forward by manufacturers to support fixed-dose combinations must be considered by an advisory committee to India’s government, the Delhi High Court has ordered in a verdict favouring Wockhardt.
India Regulation
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Latest From Biosimilars

Belgium Unveils Incentives For Biosimilar Adalimumab And Etanercept

Belgium has introduced financial incentives to encourage doctors to prescribe anti-TNF biosimilars adalimumab and etanercept outside of hospitals.

Belgium Biosimilars

European Council Brings SPC Manufacturing Waiver A Step Closer

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

Europe Manufacturing

Switching Studies Show Safety Of Celltrion's Infliximab Biosimilar In IBD

Two infliximab switching studies have provided reassuring data on the safety of Celltrion’s CT-P13 infliximab biosimilar to treat IBD. While one report explores changing pediatric patients to CT-P13 from the Remicade reference drug, the other looks at reverse switching patients from the biosimilar to the originator brand.

Biosimilars Market Intelligence
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Latest From Value-Added Medicines

Sandoz Phases US Epinephrine Entry

Sandoz will first focus on the US institutional channel on which it is increasingly concentrating its attention as it rolls out its alternative to Mylan’s EpiPen epinephrine auto-injector.
Value-Added Medicines Launches

Dr Reddy’s Growth Strategy Sets Sights On Six Spaces

Dr Reddy’s chief operating officer Erez Israeli says six key areas – the US, China, Russia, India, APIs and hospital drugs – underpin the Indian company’s growth ambitions, with small-molecule generics remaining the firm’s “bread and butter”.

United States India

Kashiv Pharma Swallows Up Adello Biologics, Becoming Kashiv BioSciences

New Jersey-based Kashiv adds biosimilar assets to its repertoire by acquiring Adello Biologics, becoming, in its own words, a “fully-integrated biosciences company with an expanded and dynamic platform for growth.” Adello’s CEO, Chintu Patel, will lead the combination.

M & A Biosimilars
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