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Interviews

Interviews

Global Harmonization Efforts Must Go Further

With global regulation of off-patent medicines continuing to evolve, IGBA secretary general Suzette Kox talks about the progress expected from regulatory harmonization for generics and a reduced clinical trial burden for biosimilars.

Regulation International

Generics Bulletin Editor’s Picks For Q1 2023

Looking back over the first quarter of 2023, Generics Bulletin executive editor Dave Wallace picks out highlights from January to March that include the launch of the first US Humira biosimilar, new leadership at the top of some of the industry’s biggest players, annual results and strategy updates, and multiple major industry conferences – as well as the launch of our annual awards.

Biosimilars Launches Leadership
 

Commercial Explore this Topic

Set Alert for Commercial

Sandoz Reveals New Headquarters Post Spin, Mid-2024 Date Outlined

Tracing its roots back to Basel in the late nineteenth century, Sandoz has confirmed the location of its new planned permanent headquarters post-spin.

Strategy Companies

Lupin Launches First Cetuximab Biosimilar In India Through Enzene Partnership

Lupin has collaborated with Alkem subsidiary Enzene Biosciences to launch the first ever cetuximab biosimilar in India. 

Biosimilars Launches

Coherus Plots ‘Lowest Price Adalimumab’ With Huge Discount, Ties Up With Mark Cuban

Coherus BioSciences had teased a “compelling value proposition” for its Yusimry (adalimumab-aqvh) biosimilar to AbbVie’s Humira blockbuster and it has delivered, with a pair of pricing strategies include one though an alliance with self-labelled “disruptor” Mark Cuban.

Biosimilars Pricing Strategies

Biocon Pumps Up For Adalimumab US Debut Amid Payer ‘Steady State’

Biocon is confident of its “four channel strategy” for the upcoming debut of biosimilar Humira in the US and also asserts it’s well positioned to compete when price cuts come into play for Sanofi’s Lantus next year.

Sales & Earnings Commercial

Glucagon And Epinephrine Continue To Drive Growth At Amphastar

Amphastar has delivered another successful quarter, bolstered by sales of glucagon and epinephrine, as it prepares to roll out a number of commercially attractive products and complete a significant branded product acquisition.

Sales & Earnings Generic Drugs

UAE’s Bioventure Is Looking For Partners To Expand

Having recently added to its biosimilars alliance with Alvotech, Dubai-based Bioventure says it is looking to expand its international reach through further partnerships.

Strategy Deals
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Policy & Regulation Explore this Topic

Set Alert for Policy and Regulation

Is It Time To Promote US FDA’s Biosimilars Office Out Of OND?

Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?

Biosimilars FDA

Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

Generic Drugs Clinical Trials

Medicines For Europe Highlights Industry Agenda

Ahead of its annual meeting in Malta in mid-June, European off-patent industry association Medicines for Europe has set out the hot topics for generics and biosimilars stakeholders that delegates will be looking to discuss.

Europe Legislation

US FDA Doesn’t Want ANDAs With Facilities Not Ready For Inspection Even Though It Can Accept Them

An agency official said the GDUFA III provision hopefully will be used for only a small number of ANDAs. We chart the approval times and first-cycle clearances over the course of the generic user fee program.

Generic Drugs Manufacturing

European Industry Voices Concern As Products Vanish From Market

A fresh report has offered stark new data on the extent to which generics are disappearing from the European market. Industry association Medicines for Europe has pointed to the risks of supply consolidation, urging both national- and EU-level action.

Generic Drugs Supply Chain

IGBA Offers Input On WHO Pandemic Accord

As the WHO seeks input on a global accord to strengthen pandemic preparedness, the IGBA has provided suggestions from the off-patent industry ahead of a key step in the drafting process later this month.

Supply Chain International
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

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

Generics Bulletin previews the most notable and anticipated events for June 2023.

Biosimilars Generic Drugs

Glucagon And Epinephrine Continue To Drive Growth At Amphastar

Amphastar has delivered another successful quarter, bolstered by sales of glucagon and epinephrine, as it prepares to roll out a number of commercially attractive products and complete a significant branded product acquisition.

Sales & Earnings Generic Drugs

UAE’s Bioventure Is Looking For Partners To Expand

Having recently added to its biosimilars alliance with Alvotech, Dubai-based Bioventure says it is looking to expand its international reach through further partnerships.

Strategy Deals
See All

Biosimilars Explore this Topic

Set Alert for Biosimilars

Lupin Launches First Cetuximab Biosimilar In India Through Enzene Partnership

Lupin has collaborated with Alkem subsidiary Enzene Biosciences to launch the first ever cetuximab biosimilar in India. 

Biosimilars Launches

Coherus Plots ‘Lowest Price Adalimumab’ With Huge Discount, Ties Up With Mark Cuban

Coherus BioSciences had teased a “compelling value proposition” for its Yusimry (adalimumab-aqvh) biosimilar to AbbVie’s Humira blockbuster and it has delivered, with a pair of pricing strategies include one though an alliance with self-labelled “disruptor” Mark Cuban.

Biosimilars Pricing Strategies

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

Generics Bulletin previews the most notable and anticipated events for June 2023.

Biosimilars Generic Drugs
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

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

Generics Bulletin previews the most notable and anticipated events for June 2023.

Biosimilars Generic Drugs

Coherus Looks To Galvanize Pegfilgrastim Biosimilar With New Formats

Coherus BioSciences spoke at length about its two marketed biosimilars, referencing Neulasta and Lucentis, during the company’s first-quarter earnings call.

Sales & Earnings Strategy

Teva Prepares To Launch LAI Risperidone After US Approval

Teva has indicated an imminent launch after gaining a long-awaited FDA approval for the Uzedy long-acting injectable risperidone 505(b)(2) hybrid product on which the firm has partnered with MedinCell. Pricing information has also been revealed.

Approvals Value-Added Medicines
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