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Neuraxpharm Expands European Reach With Dutch Operation

Neuraxpharm has made its latest move into a new European market, this time opening up a new unit in the Netherlands that will be led by the firm’s German head Philipp Pohoralek as country manager.

Strategy Leadership

Interviews

Interviews

Science-Based Thinking Promises Global Progress On Biosimilars

A science-based approach to biosimilars, exemplified by the latest statement from European regulators, makes further progress on biosimilars just a matter of time, according to Gillian Woollett, vice president and head of regulatory strategy and policy at Samsung Bioepis.

Biosimilars Regulation

Accord And Sandoz Lead Victories At GGB Awards 2022

Accord and Sandoz were the big winners at the Global Generics & Biosimilars Awards 2022 in Frankfurt, with other firms recognized including Beximco, Centrient, Dr Reddy’s, Eurofarma, Samsung Bioepis, Shanghai Henlius Biotech and Stada, as well as the US Biosimilars Forum.

Generic Drugs Biosimilars Value-Added Medicines
 

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To Prevent Shortages, US FDA Wants Sponsor To Provide Notifications Of Demand Spike

Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

Supply Chain Regulation

Neuraxpharm Expands European Reach With Dutch Operation

Neuraxpharm has made its latest move into a new European market, this time opening up a new unit in the Netherlands that will be led by the firm’s German head Philipp Pohoralek as country manager.

Strategy Leadership

Regeneron ‘Shocked’ At Biogen Lucentis Biosimilar Sales

With its own interests in the branded eye-disease space, Regeneron has commented on ranibizumab biosimilar sponsor Biogen’s fortunes during a recent conference.

Biosimilars Market Intelligence

Tambe Moves Up To Lead Biocon Biologics

Shreehas Tambe has been named as CEO of Biocon Biologics, taking over from Arun Chandavarkar, in the wake of the company’s milestone $3bn transaction for Viatris’s biosimilars business.

Leadership Executive Changes

Leonard Resignation Leaves AAM Looking For New Leadership

Dan Leonard has announced his resignation as president and CEO of the US Association for Accessible Medicines. He will be replaced on an interim basis by the group’s vice president for sciences and regulatory affairs, David Gaugh.

Leadership Executive Changes

Nichi-Iko Set To Delist In March As Tamura Steps Down As CEO

After nearly two difficult years for Nichi-Iko Pharmaceutical, the firm has announced at it will be acquired by a private equity fund and delisted from the Toyko Stock Exchange in 2023 and its CEO will step down from his post.

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Policy & Regulation Explore this Topic

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To Prevent Shortages, US FDA Wants Sponsor To Provide Notifications Of Demand Spike

Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

Supply Chain Regulation

Science-Based Thinking Promises Global Progress On Biosimilars

A science-based approach to biosimilars, exemplified by the latest statement from European regulators, makes further progress on biosimilars just a matter of time, according to Gillian Woollett, vice president and head of regulatory strategy and policy at Samsung Bioepis.

Biosimilars Regulation

Finnish Biosimilar Substitution Proposals Get Pushback From Industry

Finnish government proposals to introduce pharmacy-level substitution for biosimilars have been criticized by the country’s generics and biosimilars industry association.

Biosimilars Regulation

Humira LOE Is ‘Uncharted Territory’ As Fierce Competition Expected

Discussing the latest developments in the US biosimilars market, AmerisourceBergen’s senior director of biosimilar commercialization, Brian Biehn, talks about what we can expect from competition to Humira in 2023, how the first ophthalmology biosimilars are faring, and potential changes on the horizon at the FDA that could smooth the path to market for biosimilars sponsors.

Biosimilars Market Intelligence

Brazilian Regulator Consults On Improving Rules For Registering Biosimilars

ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.

Biosimilars Regulation

Delisting Of Jazz’s Xyrem Patent In Orange Book Could Spur More Infringement Counterclaims

Jazz’s REMS patent on distribution of Xyrem does not belong in the Orange Book because it is directed to systems rather than a method of using the drug, court rules, agreeing with FTC’s analysis.

Intellectual Property Generic Drugs
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Generic Drugs Explore this Topic

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Neuraxpharm Expands European Reach With Dutch Operation

Neuraxpharm has made its latest move into a new European market, this time opening up a new unit in the Netherlands that will be led by the firm’s German head Philipp Pohoralek as country manager.

Strategy Leadership

Leonard Resignation Leaves AAM Looking For New Leadership

Dan Leonard has announced his resignation as president and CEO of the US Association for Accessible Medicines. He will be replaced on an interim basis by the group’s vice president for sciences and regulatory affairs, David Gaugh.

Leadership Executive Changes

Zydus Walks Away From US Dapagliflozin Appeal, ANDA Discontinued

In a blow to potential US generic competition, Zydus Cadila has withdrawn its appeal to an unfavorable federal ruling involving a US Farxiga (dapagliflozin) patent.

Generic Drugs Intellectual Property
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Biosimilars Explore this Topic

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Apobiologix Launches Pegfilgrastim Autoinjector In Canada

Apobiologix’s new Lapelga autoinjector that the firm has just introduced in Canada is only the second on-body pegfilgrastim device to launch after Amgen’s Neulasta original.

Canada BioPharmaceutical

Regeneron ‘Shocked’ At Biogen Lucentis Biosimilar Sales

With its own interests in the branded eye-disease space, Regeneron has commented on ranibizumab biosimilar sponsor Biogen’s fortunes during a recent conference.

Biosimilars Market Intelligence

Science-Based Thinking Promises Global Progress On Biosimilars

A science-based approach to biosimilars, exemplified by the latest statement from European regulators, makes further progress on biosimilars just a matter of time, according to Gillian Woollett, vice president and head of regulatory strategy and policy at Samsung Bioepis.

Biosimilars Regulation
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Value-Added Medicines Explore this Topic

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Rani Therapeutics: ‘We’ve Tested A Dozen Molecules, All Of Them Have Worked’

In an exclusive interview with Generics Bulletin, Talat Imran, CEO of oral-dose biologics player Rani Therapeutics, talks adalimumab, partnering opportunities and financing, in the wake of kicking off pre-clinical development of its RT-111 proposed biosimilar to Janssen’s Stelara (ustekinumab) contained in its proprietary RaniPill Go ‘robotic’ capsule.

Biosimilars Value-Added Medicines

Hyloris Ramps Up Product Expansion With New Idiopathic Rhinitis Spray

Hyloris Pharmaceuticals’ new idiopathic rhinitis treatment sets it on track to achieve its target of around 30 portfolio assets by the end of 2024. 

Value-Added Medicines Strategy

What’s Next? Five Things To Look Out For In December

In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.

Biosimilars Generic Drugs
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