New to Generics Bulletin?
Request a free trial today!
Register for our free email digests:
Register for our free email digests:
Jump To Section
Featured Stories
Germany First As Pfenex And Alvogen Biosimilar Forsteo Is Launched
After launching in the US last year, the teriparatide product developed by Pfenex and Alvogen has been introduced in Europa, via commercialization partner Theramex, beginning with Germany.
Coronavirus Spotlight
Coronavirus Spotlight
FDA Guides On Bioequivalence Studies And COVID-19
Guidance on protecting participants in bioequivalence studies during the COVID-19 pandemic has been published by the FDA.
Latest Articles
OUTLOOK 2021
In Vivo’s annual showcase of special features and industry league tables for pharma, medtech and generics companies
VIEW 2021 RANKINGS

COVID-19 Alters But Doesn’t Change M&A Machine In 2020
Mergers and acquisitions have long been a tool for value creation in the generics and biosimilars space. Even with the entire life sciences sector overwhelmed by the novel coronavirus pandemic, deals big and small continued in 2020.

US Biosimilars See A Banner Year Despite Few Approvals
With several biologic molecules opened up to true multi-source competition over the course of 2020, the US biosimilars landscape now looks very different from the start of the year.
Commercial Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Billionaire Mark Cuban Surprises With US Generics Venture
To increase transparency and affordability, American billionaire and businessman Mark Cuban has launched a US generics venture under the name ‘the Mark Cuban Cost Plus Drugs Company.’ Cuban’s new company is hoping to introduce over 100 drugs by the end of 2021 and build a pharmaceutical factory of its own by 2022.
Germany First As Pfenex And Alvogen Biosimilar Forsteo Is Launched
After launching in the US last year, the teriparatide product developed by Pfenex and Alvogen has been introduced in Europa, via commercialization partner Theramex, beginning with Germany.
Innovent Expands Internationally With Indonesia Deal
Innovent Biologics has broadened its international reach by striking a licensing deal with PT Etana Biotechnologies in Indonesia for its Byvasda bevacizumab biosimilar.
Amneal Eyes Avastin And Praises $120m Biosimilar Development Savings
Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.
With US Respiratory Pipeline Unlocked, Cipla Wants Lung Leadership
Cipla sees an incremental revenue opportunity of up to $500m for its US franchise by fiscal 2025 and expects to propel growth with strong execution of its complex generics pipeline. The company is also beginning to “lay the blueprint” in China and Brazil, it said at the J.P. Morgan Healthcare Conference.
Teva CEO Schultz: ‘Proof Is In The Pudding’ For US Biosimilars
Teva CEO Kåre Schultz believes his prediction is coming true for the Truxima biosimilar in-licensed from Celltrion, as he gave the latest update on Teva’s efforts to settle significant legal issues around the US opioid crisis.
Policy & Regulation Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Teva And Hikma Plan Long-Term Environmental Commitments
Teva has disclosed plans to focus on climate action and resilience, responsible use of natural resources and emissions, effluents and waste, as part of a long-term environmental sustainability commitment. Meanwhile, Hikma has at the same time committed “to further reducing our climate impact and improving the resilience of our business in the face of future climate change.”
New UK Biosimilars Pathway Suffers Setback
The UK’s implementation of a new national licensing framework for biosimilars has been pushed back from the start of 2021, with the MHRA citing “intense COVID-19 activities” as the cause of an indefinite delay in the consultation process.
Interchangeability, Meetings And Access Among BsUFA III Priorities
Industry stakeholders have offered their views on key priorities for the BsUFA biosimilars user-fee program ahead of its reauthorization.
UK-EU Deal Allows For ‘Significant Divergence’ In Data Protection & SPCs
The agreement on trade and cooperation between the UK and the EU requires both sides to offer regulatory data exclusivity and supplementary protection certificates, but it does not specify any minimum periods of protection.
US FDA Recalibrates Office Of Generic Drugs
As part of a wider overhaul of the FDA’s Center for Drug Evaluation and Research, the agency is reorganizing its Office of Generic Drugs, including adding a new Office of Safety and Clinical Evaluation within the OGD.
US Ruling Confirms Copaxone Is Not A Biologic
US FDA’s interpretation of ‘protein’ is reasonable and owed deference, the court concludes in tossing Teva suit which challenged Copaxone’s exclusion from list of drugs transitioned to being regulated as biologics.
Generic Drugs Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Billionaire Mark Cuban Surprises With US Generics Venture
To increase transparency and affordability, American billionaire and businessman Mark Cuban has launched a US generics venture under the name ‘the Mark Cuban Cost Plus Drugs Company.’ Cuban’s new company is hoping to introduce over 100 drugs by the end of 2021 and build a pharmaceutical factory of its own by 2022.
Teva And Hikma Plan Long-Term Environmental Commitments
Teva has disclosed plans to focus on climate action and resilience, responsible use of natural resources and emissions, effluents and waste, as part of a long-term environmental sustainability commitment. Meanwhile, Hikma has at the same time committed “to further reducing our climate impact and improving the resilience of our business in the face of future climate change.”
Amneal Eyes Avastin And Praises $120m Biosimilar Development Savings
Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.
Biosimilars Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Germany First As Pfenex And Alvogen Biosimilar Forsteo Is Launched
After launching in the US last year, the teriparatide product developed by Pfenex and Alvogen has been introduced in Europa, via commercialization partner Theramex, beginning with Germany.
Innovent Expands Internationally With Indonesia Deal
Innovent Biologics has broadened its international reach by striking a licensing deal with PT Etana Biotechnologies in Indonesia for its Byvasda bevacizumab biosimilar.
Amneal Eyes Avastin And Praises $120m Biosimilar Development Savings
Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.
Value-Added Medicines Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Amneal Eyes Avastin And Praises $120m Biosimilar Development Savings
Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.
Neuraxpharm Enters Japanese Market
Neuraxpharm has expanded its footprint outside of Europe with the launch of its first product in Japan, in the form of the Buccolam value-added midazolam product gained through a deal with Takeda.
Teva Upbeat On Risperidone Results
Following positive trial results, Teva says it is exploring options with the US FDA for filing a long-acting subcutaneous injectable version of risperidone that it is developing with MedinCell.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.