Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Featured Stories




 

Interviews

Interviews

Fixing The UK Market: Government Must Move From ‘Transactional’ To ‘Strategic’ Approach

With the UK market experiencing approval delays, shortages, and regulatory complexity, the government’s “policy vacuum” and complacent approach to off-patent medicines risk undermining the sector, says BGMA chair Diane DiGangi Trench. In an exclusive interview with Generics Bulletin, she urges a shift from a “transactional” to a “strategic” relationship with industry to fully unlock the benefits of generics and biosimilars.

United Kingdom Policy

GGB Awards Set Stage For Milan In October

The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars Value-Added Medicines
 
Commercial

Biosimilar Substitution In Medicare Part D Formularies Mid-Year Established In Final Rule

Policy may be helpful in promoting acceptance of follow-ons in Medicare but is not expected to result in near-term savings to the program.

Biosimilars Reimbursement

Emboldened In Court, Lupin Launches First US Oracea Generic At Risk

Lupin has shown its confidence in its legal position after introducing the first US generic version of Galderma’s rosacea treatment, Oracea, while the originator battles for injunctive relief.

Launches Generic Drugs

Stada Tight-Lipped On Potential Sale Amid Reports Talks Are Underway

The rumor mill is heating up on Stada’s potential sale by its owners, Bain Capital and Cinven, after seven years at the helm.

Deals Companies

Mallinckrodt Reports 2023 Results After Second Restructuring

Emerging out of its second Chapter 11 bankruptcy filing in the past four years, the company reported a slump in net sales despite positive signals in specific portfolios.

Generic Drugs Sales & Earnings
See All
Regulation

Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

Ultimate responsibility for data integrity rests with applicant, even if study is contracted out; testing site management should build a culture of quality, says the guidance, which aims to address the high-profile data integrity problems that have plagued the generic drug industry.

Generic Drugs Regulation

India IPR Realities: Pharma, Legal Heads Discuss Winds Of Change, ‘Damocles Sword’

Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.

India Intellectual Property

Outlook Turns To Marketing Strategy After Scoring EU First For Ophthalmic Bevacizumab

Outlook Therapeutics’ intravitreally injected Lytenava has won the thumbs up from the European Medicines Agency. The company is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.

Ophthalmic Approvals

Fixing The UK Market: Government Must Move From ‘Transactional’ To ‘Strategic’ Approach

With the UK market experiencing approval delays, shortages, and regulatory complexity, the government’s “policy vacuum” and complacent approach to off-patent medicines risk undermining the sector, says BGMA chair Diane DiGangi Trench. In an exclusive interview with Generics Bulletin, she urges a shift from a “transactional” to a “strategic” relationship with industry to fully unlock the benefits of generics and biosimilars.

United Kingdom Policy
See All
Generic Drugs

Emboldened In Court, Lupin Launches First US Oracea Generic At Risk

Lupin has shown its confidence in its legal position after introducing the first US generic version of Galderma’s rosacea treatment, Oracea, while the originator battles for injunctive relief.

Launches Generic Drugs

Mallinckrodt Reports 2023 Results After Second Restructuring

Emerging out of its second Chapter 11 bankruptcy filing in the past four years, the company reported a slump in net sales despite positive signals in specific portfolios.

Generic Drugs Sales & Earnings

‘That’s A Much Broader Statement’: Hikma Grilled In Amarin Vascepa Skinny-Label Appeal

Hikma may have succeeded in dismissing Amarin’s induced infringement claim against the firm over Hikma’s skinny label generic Vascepa in the US, but a panel of judges for the US Court of Appeals for the Federal Circuit challenged that the generics manufacturer’s public disclosures “sound like an actual statement, encouraging use for the broad sweep of things: that this generic can be used instead of the brand, without any narrowing.”

Legal Issues Litigation

Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

Ultimate responsibility for data integrity rests with applicant, even if study is contracted out; testing site management should build a culture of quality, says the guidance, which aims to address the high-profile data integrity problems that have plagued the generic drug industry.

Generic Drugs Regulation
See All
Generic Drugs

Emboldened In Court, Lupin Launches First US Oracea Generic At Risk

Lupin has shown its confidence in its legal position after introducing the first US generic version of Galderma’s rosacea treatment, Oracea, while the originator battles for injunctive relief.

Launches Generic Drugs

Mallinckrodt Reports 2023 Results After Second Restructuring

Emerging out of its second Chapter 11 bankruptcy filing in the past four years, the company reported a slump in net sales despite positive signals in specific portfolios.

Generic Drugs Sales & Earnings

‘That’s A Much Broader Statement’: Hikma Grilled In Amarin Vascepa Skinny-Label Appeal

Hikma may have succeeded in dismissing Amarin’s induced infringement claim against the firm over Hikma’s skinny label generic Vascepa in the US, but a panel of judges for the US Court of Appeals for the Federal Circuit challenged that the generics manufacturer’s public disclosures “sound like an actual statement, encouraging use for the broad sweep of things: that this generic can be used instead of the brand, without any narrowing.”

Legal Issues Litigation

Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

Ultimate responsibility for data integrity rests with applicant, even if study is contracted out; testing site management should build a culture of quality, says the guidance, which aims to address the high-profile data integrity problems that have plagued the generic drug industry.

Generic Drugs Regulation

Duo Falter Again On US Belbuca ANDA, Eight Years After Joining Hands

IntelGenx has once again been frustrated in its attempts to challenge Collegium’s powerful opioid Belbuca in the US, amid ongoing litigation over the brand’s three US patents that run until December 2032. Meanwhile, Teva’s desire to push on with its own January 2027 launch has been called into question.

Complete Response Letters Generic Drugs

‘Speculation Is Not Science’: Lupin Breezes Past Galderma On US Oracea Patents

Lupin received a more than favorable backing from a US district judge in Delaware, as the court shot down Galderma’s arguments that the Indian firm’s ANDA product would infringe two of its US Oracea patents.

Generic Drugs Litigation

Padagis Hit With Immediate Suit After Filing First ANDA For US Zoryve Cream

Tipped to bring in sales of $500m or more by 2030, Arcutis Biotherapeutics’ Zoryve 0.3% cream has become the target of an ANDA filed by Padagis, a partner of Sol-Gel Technologies. The originator responded with an immediate suit to shut down any potential generic launch in the near term.

Drug Review Generic Drugs

Teva, Viatris Handed Second Bite At Overturning Core US Invega Sustenna Patent

Teva and Viatris hold firm ambitions in the long-acting schizophrenia space, and have just secured a win in their endeavors by convincing the US Court of Appeals for the Federal Circuit that a lower court erred in its analysis of whether a key Invega Sustenna patent was obvious.

Intellectual Property Leadership

Lupin Sharpens Focus With Carve-Out Of Indian Trade Generics Business

Lupin has announced plans to carve out its trade generics business in India to its Lupin Life Sciences Limited subsidiary, as part of efforts to achieve “agility, better focus and growth” for the unit.

Strategy Generic Drugs

Biocon And Zentiva Hail Milestone Liraglutide Approval In UK

Biocon and Zentiva have celebrated the “first generic liraglutide approved in a major regulated/ICH market” after an endorsement from the UK’s MHRA.

Approvals Generic Drugs

Amneal Targets Limited US Ciprodex Pool With FDA Approval

The FDA has granted approval to Amneal’s ciprofloxacin/dexamethasone otic suspension ANDA product, referencing Ciprodex, adding a further drug to the company’s portfolio as the firm continues its strategic shift to complex generics.

Approvals Generic Drugs

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

Generics Bulletin previews the most noteworthy and anticipated events for April 2024.

Biosimilars Generic Drugs
See All
Biosimilars

Biosimilar Substitution In Medicare Part D Formularies Mid-Year Established In Final Rule

Policy may be helpful in promoting acceptance of follow-ons in Medicare but is not expected to result in near-term savings to the program.

Biosimilars Reimbursement

Celltrion’s Subcutaneous Infliximab Lands On Big PBM Formulary List

One down, two more to go. Celltrion seals a formulary deal with one of the top three PBMs in the US for its subcutaneous infliximab product Zymfentra.

Strategy Biosimilars

Boehringer’s Slashed Cyltezo Salesforce Reflects Struggles For US Humira Biosimilars

Boehringer Ingelheim’s decision to cut sales staff for its Cyltezo US biosimilar rival to Humira not only reflects the company’s difficulties in gaining traction for the first interchangeable version of adalimumab, but also the struggles for Humira biosimilars more widely.

Biosimilars Strategy

China’s Regulators Accept Jiuyuan Gene’s Application For Ozempic Biosimilar

Jiuyuan Gene scored a country-wide first as China’s regulator accepted its marketing application for a semaglutide biosimilar in type 2 diabetes that will be marketed as Jiyoutai.

Biosimilars Strategy
See All
Value-Added Medicines

Celltrion’s Subcutaneous Infliximab Lands On Big PBM Formulary List

One down, two more to go. Celltrion seals a formulary deal with one of the top three PBMs in the US for its subcutaneous infliximab product Zymfentra.

Strategy Biosimilars

Teva Pushes For Progress On Asthma Rescue Inhaler

Teva has struck a $150m strategic development funding agreement with Abingworth and a clinical collaboration agreement with Launch Therapeutics to accelerate development of a dual-action asthma rescue inhaler.

Deals Value-Added Medicines

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

Generics Bulletin previews the most noteworthy and anticipated events for April 2024.

Biosimilars Generic Drugs

Hyloris Reports 44% Revenue Growth Driven By Royalties In 2023

Belgian company Hyloris Pharmaceuticals has reported a 44% revenue increase in its 2023 results while doubling down on its long-standing ambition to have 30 portfolio assets in the near future.

Sales & Earnings Strategy
See All
Recent Stories

Biosimilar Substitution In Medicare Part D Formularies Mid-Year Established In Final Rule

Policy may be helpful in promoting acceptance of follow-ons in Medicare but is not expected to result in near-term savings to the program.

Biosimilars Reimbursement

Emboldened In Court, Lupin Launches First US Oracea Generic At Risk

Lupin has shown its confidence in its legal position after introducing the first US generic version of Galderma’s rosacea treatment, Oracea, while the originator battles for injunctive relief.

Launches Generic Drugs

Stada Tight-Lipped On Potential Sale Amid Reports Talks Are Underway

The rumor mill is heating up on Stada’s potential sale by its owners, Bain Capital and Cinven, after seven years at the helm.

Deals Companies

Mallinckrodt Reports 2023 Results After Second Restructuring

Emerging out of its second Chapter 11 bankruptcy filing in the past four years, the company reported a slump in net sales despite positive signals in specific portfolios.

Generic Drugs Sales & Earnings

‘That’s A Much Broader Statement’: Hikma Grilled In Amarin Vascepa Skinny-Label Appeal

Hikma may have succeeded in dismissing Amarin’s induced infringement claim against the firm over Hikma’s skinny label generic Vascepa in the US, but a panel of judges for the US Court of Appeals for the Federal Circuit challenged that the generics manufacturer’s public disclosures “sound like an actual statement, encouraging use for the broad sweep of things: that this generic can be used instead of the brand, without any narrowing.”

Legal Issues Litigation

Celltrion’s Subcutaneous Infliximab Lands On Big PBM Formulary List

One down, two more to go. Celltrion seals a formulary deal with one of the top three PBMs in the US for its subcutaneous infliximab product Zymfentra.

Strategy Biosimilars

Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan

US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.

Manufacturing Reimbursement

Dr Reddy’s Promotes Drug Access With Three Branded Deals In India

With a clear angle of increasing access to medicines in India, Dr Reddy’s signature landed on three branded deals with pharma firms, bringing more vaccines, cardiovascular and resuscitative drugs to the country.

Strategy Deals

Boehringer’s Slashed Cyltezo Salesforce Reflects Struggles For US Humira Biosimilars

Boehringer Ingelheim’s decision to cut sales staff for its Cyltezo US biosimilar rival to Humira not only reflects the company’s difficulties in gaining traction for the first interchangeable version of adalimumab, but also the struggles for Humira biosimilars more widely.

Biosimilars Strategy

China’s Regulators Accept Jiuyuan Gene’s Application For Ozempic Biosimilar

Jiuyuan Gene scored a country-wide first as China’s regulator accepted its marketing application for a semaglutide biosimilar in type 2 diabetes that will be marketed as Jiyoutai.

Biosimilars Strategy

Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

Ultimate responsibility for data integrity rests with applicant, even if study is contracted out; testing site management should build a culture of quality, says the guidance, which aims to address the high-profile data integrity problems that have plagued the generic drug industry.

Generic Drugs Regulation

Duo Falter Again On US Belbuca ANDA, Eight Years After Joining Hands

IntelGenx has once again been frustrated in its attempts to challenge Collegium’s powerful opioid Belbuca in the US, amid ongoing litigation over the brand’s three US patents that run until December 2032. Meanwhile, Teva’s desire to push on with its own January 2027 launch has been called into question.

Complete Response Letters Generic Drugs
UsernamePublicRestriction

Register