Generics Bulletin
The FDA rejection of Alvotech’s AVT06 Eylea biosimilar was revealed as part of a wider funding update outlining a $108m bond placement and continued heavy R&D investment.
UK liquids specialist Rosemont Pharmaceuticals has named industry veteran Alok Sonig as its new CEO, as the firm continues to set its sights on the US market. Meanwhile, Rosemont has also appointed Gavin Wood as chief financial officer.
Decision matches earlier Dr Reddy’s outcome, although no injunctive action involved, allowing exports to non-patent markets ahead of a post-expiry launch.
Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.
After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.
The European Commission’s pending decision for Stada-Bio-Thera could bring a second golimumab biosimilar to market, tightening competition behind Alvotech-Advanz’s early launch plans.
Sandoz said it was “asserting biosimilars leadership” as it announced the completion of a deal to acquire Just-Evotec Biologics’s Toulouse development and manufacturing site as well as an indefinite licence to the firm’s continuous manufacturing technology.
Hikma has initiated a leadership transition, with CEO Riad Mishlawi stepping down after just two years in the role, as margin pressure in its core Injectables business and operational delays weigh on performance.
After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
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.
Cipla’s rollout of Lilly’s tirzepatide second brand comes as Wegovy price cuts tighten competition in India’s fast-growing GLP-1 market.
Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.
“Section viii cannot function as Congress intended,” if a Federal Circuit ruling stands, the US solicitor general has argued as he urged the Supreme Court to review and reverse the closely-watched Hikma skinny-label Vascepa case.
Formycon has again stepped closer to financial certainty with another pembrolizumab biosimilar deal. This time, it unlocked a significant opportunity for the US and Canadian markets.
The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.
With Richard Pazdur’s abrupt exit marking the fifth CDER leadership change in a year, the AAM is urging continuity and stability amid the ongoing turbulence.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.