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Coronavirus Spotlight


OUTLOOK 2021

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


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Entries Open For The Global Generics & Biosimilars Awards 2021

Entries are now open for the Global Generics & Biosimilars Awards 2021, which will take place in Milan, Italy on 10 November.

Generic Drugs Biosimilars Value-Added Medicines

Teva: Biosimilars In The US Will Become Like Complex Generics

With a couple of major partnerships and a stable of internal projects, Teva expects to play a role in the “majority of meaningful US biosimilar launches in the next five-to-eight years,” executive vice-president for North America commercial Brendan O’Grady told Generics Bulletin in an exclusive interview.

Biosimilars Commercial Strategy
 

Commercial Explore this Topic

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Coherus Completes $50m Share Offer To Novel Partner Junshi Biosciences

Coherus BioSciences has sold a little under 2.5 million shares to partner Junshi Biosciences, giving the firm additional capital following a large debt financing last year.

Deals Financing

Alvogen’s Lotus Bags $50m Investment To Boost Access In Asia

Lotus Pharmaceuticals aims to build a stronghold in Thailand and beyond, after the Alvogen subsidiary announced a partnership with a subsidiary of Thai state-owned conglomerate PTT, which includes a $50m capital injection.

Deals Strategy

PlantForm Strikes Deal For Brazilian Pembrolizumab

Canada’s PlantForm has struck a deal with Brazil’s Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab rival to Merck’s Keytruda for the Brazilian market and potentially beyond.

Deals Biosimilars

Aurobindo’s Latest Launches Include Truvada And Atripla Rivals

Aurobindo has announced the launch of generic versions of Truvada, Atripla, Minocin and Gleevec in the US. As its generics business grows in the US, Europe, Canada and the rest of the world markets, Aurobindo plans to establish itself in China. The Indian pharma company has also announced its plan to commission new facilities to serve the external market. 

Approvals Launches

New Fresenius Kabi Chief Sen Adds Sandoz’ Pawlu

As Michael Sen takes the reins as CEO of Fresenius Kabi, Christian Pawlu has been recruited from Sandoz to head up the firm’s generics and complex formulations unit.

Appointments Leadership

Prestige And Pharmapark Add Bevacizumab To Russia Collaboration

Russia’s Pharmapark has added Prestige BioPharma’s HD204 biosimilar bevacizumab product to the firms’ commercialization partnership, two years after kicking off the partnership with trastuzumab.

Biosimilars Deals
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Policy & Regulation Explore this Topic

Set Alert for Policy and Regulation

Action Needed To Prevent Post-Brexit Catastrophe In Northern Ireland

Action is needed from both the UK government and the European Commission to prevent a collapse of Northern Ireland’s generics market, according to the BGMA.

Regulation United Kingdom

FTC Wins Backing Over Pay-For-Delay Decision

The FTC has won the backing of an appeals court over its 2019 decision that found a reverse-payment settlement deal between Impax and Endo over Opana ER to be anti-competitive and illegal.

Legal Issues Regulation

Teva Identifies ‘Problem Pattern’ Of Complex CRLs Ahead Of GDUFA III

Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.

Generic Drugs Strategy

FDA Guides On Virtual Inspections During COVID-19

Details of how the FDA plans to conduct remote evaluations of manufacturing facilities during the COVID-19 pandemic have been set out in guidance published by the US agency.

Guidance Documents Regulation

Biosimilars Bodies Urge Communication Enhancements For BsUFA III

Biosimilars industry stakeholders have suggested ways to enhance communication and improve the US regulatory pathway for biosimilars, as they weighed in on an interim assessment of the program for enhanced review transparency and communication in the Biosimilar User Fee Act II, ahead of the upcoming reauthorization of BsUFA for fiscal years 2023 through 2027 by the FDA. 

Biosimilars Regulation

Tentative Biosimilar Approvals Under Consideration By FDA

Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.

Biosimilars Regulation
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Generic Drugs Explore this Topic

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Biosimilar Education And Innovation Bills Head To Biden’s Desk

The Advancing Education on Biosimilars Act and the Ensuring Innovation Act will be looked at by the US President Joe Biden, after receiving the approval of both the Senate and the House of Representatives. The bills are aimed at lowering prescription drug costs and saving overall healthcare costs. 

United States BioPharmaceutical

Aurobindo’s Latest Launches Include Truvada And Atripla Rivals

Aurobindo has announced the launch of generic versions of Truvada, Atripla, Minocin and Gleevec in the US. As its generics business grows in the US, Europe, Canada and the rest of the world markets, Aurobindo plans to establish itself in China. The Indian pharma company has also announced its plan to commission new facilities to serve the external market. 

Approvals Launches

Teva Identifies ‘Problem Pattern’ Of Complex CRLs Ahead Of GDUFA III

Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.

Generic Drugs Strategy
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Biosimilars Explore this Topic

Set Alert for Biosimilars

Biosimilar Education And Innovation Bills Head To Biden’s Desk

The Advancing Education on Biosimilars Act and the Ensuring Innovation Act will be looked at by the US President Joe Biden, after receiving the approval of both the Senate and the House of Representatives. The bills are aimed at lowering prescription drug costs and saving overall healthcare costs. 

United States BioPharmaceutical

Amgen Tells Sandoz On Enbrel: You Lost On The Facts

Amgen has hit back at Sandoz’ petition for a writ of certiorari against a US Court of Appeals for the Federal Circuit decision that leaves the biosimilar sponsor unable to market its Enbrel biosimilar more than three decades after the biologic was first launched.

Biosimilars Intellectual Property

PlantForm Strikes Deal For Brazilian Pembrolizumab

Canada’s PlantForm has struck a deal with Brazil’s Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab rival to Merck’s Keytruda for the Brazilian market and potentially beyond.

Deals Biosimilars
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Value-Added Medicines Explore this Topic

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Glenmark Finds Canadian Ryaltris Partner

Glenmark has struck the latest in a series of commercialization deals for its Ryaltris nasal spray in the form of a ten-year alliance with Bausch Health for the Canadian market.

Deals Value-Added Medicines

Hyloris Sets Out Plans To Expand Its Pipeline

After partnering with companies like Purna Female Healthcare and AFT Pharmaceuticals, Belgian value-added medicines specialist Hyloris has announced plans to add three new products to its pipeline in the coming months with a goal of having 14 commercial products by 2024. 

Europe Sales & Earnings

UK Set To Launch Drug Repurposing Project

Licensing new uses of existing medicines has several benefits over off-label use, such as offering assurances that the indication is evidence based and subject to an ongoing safety monitoring program, according to a new report.

Value-Added Medicines Europe
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