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Viatris Swats Away Concerns Over Divestment Valuations

Viatris remains committed to completing the sale of its global biosimilars unit to Biocon Biologics, while continuing efforts to generate up to $9bn in pre-tax proceeds by the end of 2023 from divestments.

Strategy Deals

Interviews

Interviews

Hikma Will Push Harder To Make M&A Happen

Following a challenging first half for Hikma, executive chairman and CEO Said Darwazah talks to Generics Bulletin about how the firm is planning to be more active in making deals happen, as well as how it plans to address pressures on its Generics division that led to two consecutive downgrades in guidance this year.

Strategy M & A

One Month Remains To Enter GGB Awards

Just one month remains until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

Generic Drugs Biosimilars Value-Added Medicines
 

Commercial Explore this Topic

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EMA To Update Active Substances Guide To Address Nitrosamine Contamination

The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.

Manufacturing Regulation

Viatris Swats Away Concerns Over Divestment Valuations

Viatris remains committed to completing the sale of its global biosimilars unit to Biocon Biologics, while continuing efforts to generate up to $9bn in pre-tax proceeds by the end of 2023 from divestments.

Strategy Deals

ANI Brings In Record Revenues As Cortrophin Rollout Ploughs Ahead

ANI Pharmaceuticals has recorded its highest-ever quarterly revenue of $73.9m during Q2, following the launch of its cortrophin gel and a substantial growth in generics revenue.

Sales & Earnings Launches

Viatris Slashes Full-Year Revenue Guidance By $800m

Viatris is committing to earlier EBITDA and free cash flow targets for 2022, although it now expects to lose a chunk of revenues for the full year amid severe and sustained foreign currency exposure.

Sales & Earnings Strategy

Hikma Will Push Harder To Make M&A Happen

Following a challenging first half for Hikma, executive chairman and CEO Said Darwazah talks to Generics Bulletin about how the firm is planning to be more active in making deals happen, as well as how it plans to address pressures on its Generics division that led to two consecutive downgrades in guidance this year.

Strategy M & A

Amneal Expects Host Of New Launches To Drive Firm To Success

Despite a couple of setbacks during Q2, Amneal has sustained continual growth across its business, particularly in the injectables space.

Sales & Earnings Launches
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Policy & Regulation Explore this Topic

Set Alert for Policy and Regulation

EMA To Update Active Substances Guide To Address Nitrosamine Contamination

The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.

Manufacturing Regulation

Study Offers Support For Biosimilar-To-Biosimilar Switching

A new paper has examined the issue of biosimilar-to-biosimilar switching, concluding that it is a safe and effective clinical practice but highlighting a lack of current health authority regulations or guidance on the subject.

Biosimilars Regulation

AAM Laments Price Negotiation Legislation Passing US Senate

The AAM has criticized the passage of the US Inflation Reduction Act though the country’s Senate, claiming that the legislation’s “flawed framework for government price setting” will chill generic and biosimilar development and will reduce patient access.

Legislation Pricing Strategies

Cutting Through The Confusion On US Biosimilar Interchangeability

Amid ongoing confusion around the US interchangeability designation for biosimilars, Joseph Park and Gillian Woollett of Samsung Bioepis talk to Generics Bulletin about the risks of misinformation, the importance of educational efforts, and how language is shaping certain misunderstandings around biosimilars.

Biosimilars Regulation

Cimerli Interchangeable Biosimilar Approved Without Switching Data

Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.

Approvals Biosimilars

One Year On, FDA Generic Drug Cluster Focuses On Facilitating Collaboration

Following its inaugural year, the FDA’s Generic Drug Cluster has formed data sharing arrangements concerning a number of vital indications.

Generic Drugs Review Pathway
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

ANI Brings In Record Revenues As Cortrophin Rollout Ploughs Ahead

ANI Pharmaceuticals has recorded its highest-ever quarterly revenue of $73.9m during Q2, following the launch of its cortrophin gel and a substantial growth in generics revenue.

Sales & Earnings Launches

Entry Deadline Looms For GGB Awards

There is now just one week to go until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

Generic Drugs Biosimilars

UK Alendronate Prices Explode In July

An average price rise of over 1,400% was seen for alendronate 70mg tablets in the UK last month, as average prices for a host of other generics more than doubled.

Market Intelligence Pricing Strategies
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Biosimilars Explore this Topic

Set Alert for Biosimilars

Viatris Swats Away Concerns Over Divestment Valuations

Viatris remains committed to completing the sale of its global biosimilars unit to Biocon Biologics, while continuing efforts to generate up to $9bn in pre-tax proceeds by the end of 2023 from divestments.

Strategy Deals

Entry Deadline Looms For GGB Awards

There is now just one week to go until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

Generic Drugs Biosimilars

Study Offers Support For Biosimilar-To-Biosimilar Switching

A new paper has examined the issue of biosimilar-to-biosimilar switching, concluding that it is a safe and effective clinical practice but highlighting a lack of current health authority regulations or guidance on the subject.

Biosimilars Regulation
See All

Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

Entry Deadline Looms For GGB Awards

There is now just one week to go until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

Generic Drugs Biosimilars

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

A busy August brings patent expiries, biosimilar target action dates and the potential for a major change to biosimilar prescribing guidelines in Germany.

Biosimilars Generic Drugs

Following Positive IIb Study Data, Can 180 Life Sciences Clear The Next Regulatory Hurdle?

180 Life Sciences has found that adalimumab can effectively treat nodule hardness and size in Dupuytren’s disease during a Phase IIb study. But, the company’s CEO Jim Woody tells Generics Bulletin, regulators in the UK and US have requested more information before they will press on with authorization.

Regulation Biosimilars
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