Sandoz has responded to recent rumors that parent company Novartis is favoring a spinoff of the generics and biosimilars business over a sale or retention, insisting that “all options remain open” as a strategic review of the unit continues.

Publisher’s Spotlight: Citeline, the publisher of Generics Bulletin, is to merge with fellow pharmaceutical solutions provider Norstella.

Latvia’s Grindeks has set out plans to expand internationally, including by opening new subsidiaries in the US, Switzerland and EU, following a year of growth for the company.

Henlius has administered the first dose in its international Phase III trial into its denosumab biosimilar candidate, HLX14. The firm has also revealed that its new Songjiang plant has been granted GMP equivalence with EU practices.

Glenmark has moved to bolster its over-the-counter business in the US by acquiring a portfolio of approved generic OTC products from Wockhardt.

The Securities and Exchange Board of India has warned Aurobindo that it did not disclose sufficient information about a US FDA warning letter that it received in connection with its Unit 1 API facility in Hyderabad early this year.

The US FDA reports that GDUFA met all of its 11 performance enhancement goals in FY 2021, while BsUFA is on track to meet 16 of 27 of its performance enhancement goals.

This month, long-awaited new pricing measures in Canada will come into force, while several trials will either kick off or end, including a liability opioids case involving Teva in San Francisco and Hatch-Waxman litigation over Otsuka/Lundbeck’s Rexulti.

The US marketplace for biosimilars is accelerating faster than the EU at a similar point in its existence, based on approval rates, Amgen has observed in a preview of its 2022 trends in biosimilars report that also offers new data on pricing and uptake.

Senators Maria Cantwell and Chuck Grassley have introduced a bill which would limit pharmacy benefit managers’ ability to engage in “unfair and deceptive” business practices, a move which has been welcomed by the Biosimilars Forum.

The Securities and Exchange Board of India has warned Aurobindo that it did not disclose sufficient information about a US FDA warning letter that it received in connection with its Unit 1 API facility in Hyderabad early this year.

Following decisions by the EMA’s CHMP to deny Prestige Biopharma a marketing authorization for its trastuzumab biosimilar and to suspend the marketing authorizations of dozens of generics due to concerns over bioequivalence tests, the European regulator has confirmed it will review the opinions.

The US FDA reports that GDUFA met all of its 11 performance enhancement goals in FY 2021, while BsUFA is on track to meet 16 of 27 of its performance enhancement goals.

Savings made through the use of generics and biosimilars have been highlighted by the UK’s NHS, with the organization pointing to savings of £1.2bn over three years, a third of which came from Humira biosimilars alone.

This month, long-awaited new pricing measures in Canada will come into force, while several trials will either kick off or end, including a liability opioids case involving Teva in San Francisco and Hatch-Waxman litigation over Otsuka/Lundbeck’s Rexulti.

The US FDA reports that GDUFA met all of its 11 performance enhancement goals in FY 2021, while BsUFA is on track to meet 16 of 27 of its performance enhancement goals.

Savings made through the use of generics and biosimilars have been highlighted by the UK’s NHS, with the organization pointing to savings of £1.2bn over three years, a third of which came from Humira biosimilars alone.

This month, long-awaited new pricing measures in Canada will come into force, while several trials will either kick off or end, including a liability opioids case involving Teva in San Francisco and Hatch-Waxman litigation over Otsuka/Lundbeck’s Rexulti.

Adalimumab could find itself with a tenth official indication, after 180 Life Sciences found that it was able to effectively treat nodule hardness and size in Dupuytren’s disease during a phase IIb study.

In June, Medicines for Europe will host its annual and legal affairs conferences in Barcelona, while on the commercial side Hikma’s CEO Siggi Olafsson is to resign from the London-listed company.

The EMA’s CHMP has issued a positive opinion for the Kinpeygo budesonide 4mg modified-release hard capsules hybrid medicine developed by Calliditas that will be marketed in Europe by Stada. Meanwhile, four generics from Accord, Fresenius Kabi, Gedeon Richter and Sun have also been endorsed by the committee.