Value Added Medicines
Samsung Bioepis’ explorations for an alternate semaglutide formulation will be powered by G2GBIO’s microsphere technology.
NRx says the FDA has identified no bioequivalence deficiencies in its Ketafree ANDA, clearing a key hurdle ahead of a potential mid-2026 decision as the firm pursues parallel generic and innovative ketamine strategies.
AAM president and CEO John Murphy summarized a year of progress for the off-patent industry in front of an audience of generics and biosimilars industry delegates at the AAM’s Access! 2026 annual conference – but also said more efforts were needed to create a sustainable future environment.
After multiple knockbacks from the US FDA over its Lytenava ophthalmic formulation of bevacizumab, Outlook Therapeutics is hoping to resolve issues with the agency. It said the latest complete response letter was “inconsistent” with the BLA's evidence and “unexpected” after earlier FDA advice.
After taking the reins as president of Medicines for Europe at the start of 2026, Zentiva CEO Steffen Saltofte sets out priorities for the group that include ensuring access to medicines, industry resilience and competitiveness, harmonized regulation, and sustainability for the off-patent sector.
Teva is lining up Europe as the next regulatory market for its long-acting injectable olanzapine, following its US filing late last year, as the company looks to build a global schizophrenia franchise.
Hyloris and Orion continue to build on their partnership with another value-added medicine collaboration in Europe.
European CNS specialist rolls out a value-added methylphenidate and a first-to-market guanfacine generic as it sharpens its European ADHD strategy.
Management says it is prepared to sacrifice early volume if pricing fails to reflect the drug’s role in moderate to severe schizophrenia.
Viatris is entering the new year with several key achievements under its belt.
Outlook Therapeutics has once again been frustrated in its attempts to gain US FDA approval for an ophthalmic formulation of bevacizumab – and the latest complete response letter from the agency does not seem to offer a clear path ahead.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.
Zydus inks a new 505(b)(2) oncology deal, taking over the commercialization of RK Pharma’s undisclosed sterile injectable in the US.
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
Teva is continuing to decide whether to speed up the FDA review time for its proposed long-acting olanzapine injectable, though the company has numerous options for deploying its priority review voucher across a busy late-stage pipeline.
Outlook Therapeutics believes its revised filing addresses the FDA’s sole remaining concern from an August complete response letter, setting up a potential mid-2026 decision on its wet AMD therapy.
Sandoz triumphed across four categories in the Global Generics & Biosimilars Awards 2025, with other winners including Accord, Adalvo, Amneal, Aurobindo, Cencora, Centrient, CNX Therapeutics, Hikma and Samsung Bioepis, as well as the AAM and its Biosimilars Council.
Glaukos’ FDA approval for Epioxa (riboflavin 5'-phosphate) under the 505(b)(2) pathway marks a major advance in keratoconus care, offering a less invasive, epithelium-on alternative that is set to launch in early 2026 with patient access programs.
As the FDA reviews its lead ADHD candidate, a dexmethylphenidate hybrid, Cingulate is pairing scale-up manufacturing with AI-driven marketing to smooth its transition into commercialization.