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Who’s Hired? New Mithra CEO Mulls Selling Generics Business
Mithra’s new CEO has immediately signaled a potential sale for the firm’s generics business as it looks to focus on branded assets in women’s health. Meanwhile, Sawai has reorganized its management team, the longtime chair of Viatris is moving on to another role, and a former AAM vice-president has joined Sandoz.
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.
Latest Articles
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.
Commercial Explore this Topic
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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.
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.
Who’s Hired? New Mithra CEO Mulls Selling Generics Business
Mithra’s new CEO has immediately signaled a potential sale for the firm’s generics business as it looks to focus on branded assets in women’s health. Meanwhile, Sawai has reorganized its management team, the longtime chair of Viatris is moving on to another role, and a former AAM vice-president has joined Sandoz.
Yaral To Expand Burgeoning Generics Portfolio With Support From Eversana
With three additional commercial launches lined up for 2023, Yaral has opted to expand its pre-existing partnership with life sciences service provider Eversana to support these activities.
Sandoz Follows US Denosumab Filing With European Acceptance
Sandoz has confirmed dual European filings for its denosumab biosimilar rival to Prolia and Xgeva, a few months after it submitted its candidate in the US.
Alvotech Makes Multiple Moves As It Allies With Advanz For Five European Biosimilars
In a busy week for Alvotech, the firm has announced an expansion of its partnership with Advanz to cover five further European biosimilars, at the same time as revealing two new pipeline assets. Meanwhile, the company has also dropped three products from an existing European partnership with Stada and has also terminated a development deal with BiosanaPharma.
Policy & Regulation Explore this Topic
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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.
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.
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.
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.
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.
Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars
Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.
Generic Drugs Explore this Topic
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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.
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.
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.
Biosimilars Explore this Topic
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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.
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.
Sandoz Follows US Denosumab Filing With European Acceptance
Sandoz has confirmed dual European filings for its denosumab biosimilar rival to Prolia and Xgeva, a few months after it submitted its candidate in the US.
Value-Added Medicines Explore this Topic
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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.
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.
What’s Next? Five Things To Look Out For In May
Generics Bulletin previews the most notable and anticipated events for May 2023.
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