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Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod

Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.

Biosimilars Europe

Coronavirus Spotlight

Coronavirus Spotlight

EU’s Health Emergency Response Plans Must Address Existing Flaws

The EU’s creation of a Health Emergency Response Authority to deal with future health threats has been welcomed by off-patent industry association Medicines for Europe. However, the organization pointed out current policy and regulatory weaknesses that must be addressed if HERA is to be successful.

Policy Regulation

Interviews

Interviews

‘Critical To Bring Back Domestic Manufacturing Of Key Essentials’ Insists Phlow CEO

In an exclusive interview with Generics Bulletin, Phlow Corp CEO Eric Edwards has criticized the growing list of drug shortages in the US. He outlined the government-backed company’s objective of tackling drug shortages and supply chain vulnerabilities, to create a national stockpile of essential medicines.

United States Generic Drugs




OUTLOOK 2021



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




VIEW 2021 RANKINGS




Shortlist Revealed For GGB Awards

Finalists across all 14 categories of the Global Generics & Biosimilars Awards 2021 have been revealed ahead of the awards ceremony on 10 November, following record entries this year.

Generic Drugs Biosimilars Value-Added Medicines
 

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Biocon Biologics And Serum Institute Join Forces

Serum to hold 15% in Biocon arm Biocon Biologics as part of a broad alliance that expects to leverage the partners' strengths and resources in vaccines and biologics. Pursuing opportunities based on the hot mRNA technology platform appears firmly on the table.

Deals India

Philip Morris Closes In On Vectura As £1.1bn Offer Passes Threshold

Philip Morris once again pledged to up R&D in Vectura after its £1.1bn takeover offer for the UK-based inhalation specialist became unconditional, following the tobacco giant’s acrimonious face-off with private equity Carlyle earlier this year.

Companies Deals

Lupin Reaches Quarter-Of-A-Billion Dollar Deal Over Glumetza Antitrust Claims

Lupin has agreed to pay $248m to settle the majority of antitrust claims against the company alleging that it caused and enabled the prolonged delayed launch of generic Glumetza, which subsequently saw a price hike of more than 800% by originator Valeant, now Bausch Health.

Deals Intellectual Property

BioFactura’s Ustekinumab Biosimilar To Be Trialed As ‘Robotic’ Pill

BioFactura, which is already using its ‘StableFast’ technology platform to develop its biosimilar ustekinumab candidate, has allied with fellow US-based biotech Rani Therapeutics to see if the biologic can be formulated into Rani’s proprietary ‘robotic’ pill.

Biosimilars Value-Added Medicines

Alkem Delivers Strong Quarter With Domestic Recovery

India’s Alkem has delivered a strong quarter with a boost in its domestic business on the back of “strong volume-led growth in the acute therapies and faster than market growth in chronic therapies.” However, the company saw a slight YoY decline in the US.

Sales & Earnings India

JHL Biotech Executives Convicted Over Trade Secrets Theft

Two former JHL Biotech executives, Racho Jordanov and Rose Lin, have been convicted in the US of conspiracy to commit trade secret theft and wire fraud after submitting plea agreements. Meanwhile, the company – now named Eden Biologics – has just announced a change of CEO.

Legal Issues Biosimilars
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Policy & Regulation Explore this Topic

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EU’s Health Emergency Response Plans Must Address Existing Flaws

The EU’s creation of a Health Emergency Response Authority to deal with future health threats has been welcomed by off-patent industry association Medicines for Europe. However, the organization pointed out current policy and regulatory weaknesses that must be addressed if HERA is to be successful.

Policy Regulation

FDA And EMA Collaborate On Advice For Complex Generics And Hybrids

The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.

Regulation Europe

AAM Applauds HHS For Acknowledging Brand-Driven Cost Increases

The AAM has applauded US proposals to lower drug prices, following the development of the HHS’s 45-day plan in response to president Joe Biden’s executive order on promoting competition. However, AAM chief executive Dan Leonard has criticized Congressional proposals to weaken the 180-day incentive for first generics and curtail patent settlement agreements as “misguided.”

Policy Pricing Debate

FDA Airs ‘Concerns’ Over IP Barriers

Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’

Intellectual Property Policy

Alvotech Champions Switching Data As Clock Ticks On Adalimumab Filing

Before the month is out, Alvotech hopes to hear back from the US FDA for its AVT02 high-concentration 100mg/ml biosimilar adalimumab candidate. The Icelandic firm, which remains embroiled in litigation with originator AbbVie, has reported top-line results from its key switching study. 

Biosimilars Clinical Trials

FDA Official Foresees Reduced Biosimilar Data Burden

New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.

Biosimilars Drug Approval Standards
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Generic Drugs Explore this Topic

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Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod

Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.

Biosimilars Europe

AAM Warns Of Dangerous Precedent In Vascepa 'Skinny Label' Case

By allowing Amarin’s allegation of induced infringement against Hikma over its generic version of Vascepa to proceed, a US court is jeopardizing the ‘skinny label’ system that allows generics to carve out patented indications from their labels under the Hatch-Waxman framework, according to the AAM.

Legal Issues Intellectual Property

Lupin Reaches Quarter-Of-A-Billion Dollar Deal Over Glumetza Antitrust Claims

Lupin has agreed to pay $248m to settle the majority of antitrust claims against the company alleging that it caused and enabled the prolonged delayed launch of generic Glumetza, which subsequently saw a price hike of more than 800% by originator Valeant, now Bausch Health.

Deals Intellectual Property
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Biosimilars Explore this Topic

Set Alert for Biosimilars

Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod

Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.

Biosimilars Europe

New Zealand’s Pharmac Mulls Amgevita Listing

New Zealand’s Pharmac pharmaceutical management agency is considering funding Amgen’s Amgevita adalimumab biosimilar rather than the Humira reference brand from early 2022.

Biosimilars Reimbursement

Samsung Bioepis Boasts Positive Data On Lucentis And Herceptin Biosimilars

Ahead of launching potentially its Lucentis biosimilar in the EU early next year, Samsung Bioepis has reported two lots of positive analysis involving its Byooviz biosimilar, at the same time as it disclosed the findings of a five-year follow-up study for its trastuzumab biosimilar, Ontruzant.

Biosimilars Clinical Trials
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

FDA And EMA Collaborate On Advice For Complex Generics And Hybrids

The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.

Regulation Europe

BioFactura’s Ustekinumab Biosimilar To Be Trialed As ‘Robotic’ Pill

BioFactura, which is already using its ‘StableFast’ technology platform to develop its biosimilar ustekinumab candidate, has allied with fellow US-based biotech Rani Therapeutics to see if the biologic can be formulated into Rani’s proprietary ‘robotic’ pill.

Biosimilars Value-Added Medicines

Intas And Arecor Ally On Value-Added Development

Intas and Arecor have struck an exclusive licensing deal that will see the pair use Arecor’s proprietary Arestat formulation technology to develop value-added medicines, in particular for use outside of the hospital setting.

Deals Value-Added Medicines
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