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Alvotech Eyes $450m Funding And Public Listing With SPAC Merger

Eight years after its inception, pure-play biosimilars company Alvotech has announced plans to list on the NASDAQ via a SPAC merger that will deliver hundreds of millions in cash to fund product development and future growth.

M & A Deals

Coronavirus Spotlight

Coronavirus Spotlight

European Industry Urges State Aid Changes To Allow COVID Recovery

A five-year period of temporary relief from EU state aid rules should be introduced for countries willing to invest in API and medicine production, Medicines for Europe has urged, insisting that current restrictions do not allow the investment necessary to bolster the supply chain in the wake of COVID-19.

Europe Policy

Interviews

Interviews

Viatris CEO Talks Integration, Roadmap And Interchangeable Biosimilars

As CEO Michael Goettler provides an update on the progress made by Viatris in its first year as a combined company, he also offers Generics Bulletin hints as to the detailed strategy that will be unveiled at the firm’s upcoming investor day and explains how biosimilars – including interchangeable Semglee (insulin glargine) – and complex generics are important components of the firm’s future growth plans.

Strategy M & A




OUTLOOK 2021



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




VIEW 2021 RANKINGS




Generics Bulletin Editor’s Picks For Q3 2021

Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.

Generic Drugs Biosimilars Strategy
 

Commercial Explore this Topic

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Prestige Plans ‘Strong Price Competitiveness’ For Its Adalimumab Biosimilar

As Prestige BioPharma announced plans for Phase I and Phase III trials of its PBP1502 proposed adalimumab biosimilar, as well as expected filing dates in the EU and US, the company outlined how it believes its proprietary technology will allow its Humira rival to compete aggressively on price.

Biosimilars Strategy

Alvotech Eyes $450m Funding And Public Listing With SPAC Merger

Eight years after its inception, pure-play biosimilars company Alvotech has announced plans to list on the NASDAQ via a SPAC merger that will deliver hundreds of millions in cash to fund product development and future growth.

M & A Deals

Biocon Expands Into Middle East With Tabuk Partnership

Biocon is set to bolster its planned expansion into the MENA region through a partnership with Saudi firm Tabuk Pharmaceuticals, which will commercialize select Biocon generics in the Middle East.

Deals Strategy

Piramal Dreams Big, Wants To Be In Top Five India-Listed Pharma

Nandini Piramal, executive director of Piramal Enterprises, discusses how things have shaped the group's pharma business, its continuing appetite for acquisitions, efforts to de-risk the supply chain for key starting materials and the outsourcing  “framework” deployed by industry.

Strategy India

Lupin Partners With Biomm To Launch Pegfilgrastim Biosimilar In Brazil

Indian pharma firm Lupin has partnered with Biomm to market its proposed Neulasta biosimilar in Brazil, as it comes to the end of a tumultuous 2021.

Biosimilars Deals

Sawai To Take Over Facilities Owned By Scandal-Hit Kobayashi Kako

Kobayashi Kako has agreed to transfer ownership of eight of its production, research and distribution facilities to Sawai, which will use them to expand the manufacturing of its own generics. Business was suspended at Kobayashi Kako for 116 days this year after the company’s manufacturing deficiencies were linked to two deaths.

Deals Generic Drugs
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Policy & Regulation Explore this Topic

Set Alert for Policy and Regulation

AAM Blasts Build Back Better But Bernstein Offers Balance

Biosimilars could be affected significantly by Build Back Better’s drug price negotiations provision, but industry associations and analysts differ on just how much.

Legislation United States

Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Generic Drugs User Fees

FDA Takes Cues From Feedback On GDUFA Research Priorities

The FDA has outlined how it has incorporated feedback on its GDUFA science and research priorities for FY2022 from a public workshop held earlier this year, across issues including harmonization of bioequivalence standards, nitrosamine impurities, and the use of AI to support generic drug development.

Regulation Generic Drugs

British Columbia Adds Insulins To Its Biosimilar Switching Policy

Patients taking Humalog and NovoRapid will have six months to switch to their biosimilar equivalents after British Columbia added the rapid-acting insulins to its biosimilar switching policy.

Biosimilars Policy

Australian Body Welcomes Passage Of Shortages Law

Legislation setting out measures to mitigate shortages in Australia has been passed by the country’s senate, incorporating into law key provisions of new five-year pact between the off-patent industry and the government.

Legislation Regulation

Medicines For Europe Calls For Security Of Supply Legislation

Medicines for Europe has urged the European Commission to enshrine security of supply considerations for essential medicines into legislature. Without these, additional cost containment measures for off-patent medicines under consideration by member states may ultimately threaten access by making production unsustainable for manufacturers.

Europe Policy
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Generic Drugs User Fees

Biocon Expands Into Middle East With Tabuk Partnership

Biocon is set to bolster its planned expansion into the MENA region through a partnership with Saudi firm Tabuk Pharmaceuticals, which will commercialize select Biocon generics in the Middle East.

Deals Strategy

FDA Takes Cues From Feedback On GDUFA Research Priorities

The FDA has outlined how it has incorporated feedback on its GDUFA science and research priorities for FY2022 from a public workshop held earlier this year, across issues including harmonization of bioequivalence standards, nitrosamine impurities, and the use of AI to support generic drug development.

Regulation Generic Drugs
See All

Biosimilars Explore this Topic

Set Alert for Biosimilars

AAM Blasts Build Back Better But Bernstein Offers Balance

Biosimilars could be affected significantly by Build Back Better’s drug price negotiations provision, but industry associations and analysts differ on just how much.

Legislation United States

Prestige Plans ‘Strong Price Competitiveness’ For Its Adalimumab Biosimilar

As Prestige BioPharma announced plans for Phase I and Phase III trials of its PBP1502 proposed adalimumab biosimilar, as well as expected filing dates in the EU and US, the company outlined how it believes its proprietary technology will allow its Humira rival to compete aggressively on price.

Biosimilars Strategy

Alvotech Eyes $450m Funding And Public Listing With SPAC Merger

Eight years after its inception, pure-play biosimilars company Alvotech has announced plans to list on the NASDAQ via a SPAC merger that will deliver hundreds of millions in cash to fund product development and future growth.

M & A Deals
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Value-Added Medicines Explore this Topic

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Mayne And Mithra Receive Australian Nextstellis Approval

Mayne Pharma and Mithra have revealed launch plans in Australia for their Nextstellis oral contraceptive that combines the novel estrogen estetrol with drospirenone, following approval by the TGA.

Value-Added Medicines Approvals

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

As 2021 draws to a close, Coherus BioSciences awaits word on its FDA filing for biosimilar Humira, while Pfizer plots a submission for a designation for interchangeability, aiming to emulate that enjoyed by Boehringer Ingelheim’s Cyltezo. Aurobindo will also plan for the exit of popular managing director Narayanan Govindarajan.

Biosimilars Generic Drugs

ANI Pharmaceuticals Completes $210m Novitium Acquisition

ANI Pharmaceuticals has completed its acquisition of niche generics specialist Novitium Pharma, securing access to a pipeline of generics and 505(b)(2) candidates that has expanded further since the deal was announced earlier in the year.

Deals M & A
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