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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.

Biosimilars Launches

Coronavirus Spotlight


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.

M & A Deals Market Intelligence

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.

Biosimilars United States Market Intelligence
 

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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. 

Generic Drugs Manufacturing

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.

Biosimilars Launches

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.

Biosimilars Deals

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 Generic Drugs

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.

Strategy Respiratory

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.

Biosimilars Legal Issues
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Policy & Regulation Explore this Topic

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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.”

Generic Drugs Policy

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.

Biosimilars Regulation

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.

Biosimilars FDA

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.

Intellectual Property Regulation

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.

Regulation FDA

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.

Legal Issues Generic Drugs
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Generic Drugs Explore this Topic

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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. 

Generic Drugs Manufacturing

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.”

Generic Drugs Policy

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 Generic Drugs
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Biosimilars Explore this Topic

Set Alert for Biosimilars

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.

Biosimilars Launches

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.

Biosimilars Deals

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 Generic Drugs
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

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 Generic Drugs

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.

Strategy Japan

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.

Value-Added Medicines Clinical Trials
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