As Prestige BioPharma announced plans for Phase I and Phase III trials of its PBP1502 proposed adalimumab biosimilar, as well as expected filing dates in the EU and US, the company outlined how it believes its proprietary technology will allow its Humira rival to compete aggressively on price.

Eight years after its inception, pure-play biosimilars company Alvotech has announced plans to list on the NASDAQ via a SPAC merger that will deliver hundreds of millions in cash to fund product development and future growth.

Biocon is set to bolster its planned expansion into the MENA region through a partnership with Saudi firm Tabuk Pharmaceuticals, which will commercialize select Biocon generics in the Middle East.

Nandini Piramal, executive director of Piramal Enterprises, discusses how things have shaped the group's pharma business, its continuing appetite for acquisitions, efforts to de-risk the supply chain for key starting materials and the outsourcing  “framework” deployed by industry.

Indian pharma firm Lupin has partnered with Biomm to market its proposed Neulasta biosimilar in Brazil, as it comes to the end of a tumultuous 2021.

Kobayashi Kako has agreed to transfer ownership of eight of its production, research and distribution facilities to Sawai, which will use them to expand the manufacturing of its own generics. Business was suspended at Kobayashi Kako for 116 days this year after the company’s manufacturing deficiencies were linked to two deaths.

Biosimilars could be affected significantly by Build Back Better’s drug price negotiations provision, but industry associations and analysts differ on just how much.

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

The FDA has outlined how it has incorporated feedback on its GDUFA science and research priorities for FY2022 from a public workshop held earlier this year, across issues including harmonization of bioequivalence standards, nitrosamine impurities, and the use of AI to support generic drug development.

Patients taking Humalog and NovoRapid will have six months to switch to their biosimilar equivalents after British Columbia added the rapid-acting insulins to its biosimilar switching policy.

Legislation setting out measures to mitigate shortages in Australia has been passed by the country’s senate, incorporating into law key provisions of new five-year pact between the off-patent industry and the government.

Medicines for Europe has urged the European Commission to enshrine security of supply considerations for essential medicines into legislature. Without these, additional cost containment measures for off-patent medicines under consideration by member states may ultimately threaten access by making production unsustainable for manufacturers.

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Biocon is set to bolster its planned expansion into the MENA region through a partnership with Saudi firm Tabuk Pharmaceuticals, which will commercialize select Biocon generics in the Middle East.

The FDA has outlined how it has incorporated feedback on its GDUFA science and research priorities for FY2022 from a public workshop held earlier this year, across issues including harmonization of bioequivalence standards, nitrosamine impurities, and the use of AI to support generic drug development.

Biosimilars could be affected significantly by Build Back Better’s drug price negotiations provision, but industry associations and analysts differ on just how much.

As Prestige BioPharma announced plans for Phase I and Phase III trials of its PBP1502 proposed adalimumab biosimilar, as well as expected filing dates in the EU and US, the company outlined how it believes its proprietary technology will allow its Humira rival to compete aggressively on price.

Eight years after its inception, pure-play biosimilars company Alvotech has announced plans to list on the NASDAQ via a SPAC merger that will deliver hundreds of millions in cash to fund product development and future growth.

Mayne Pharma and Mithra have revealed launch plans in Australia for their Nextstellis oral contraceptive that combines the novel estrogen estetrol with drospirenone, following approval by the TGA.

As 2021 draws to a close, Coherus BioSciences awaits word on its FDA filing for biosimilar Humira, while Pfizer plots a submission for a designation for interchangeability, aiming to emulate that enjoyed by Boehringer Ingelheim’s Cyltezo. Aurobindo will also plan for the exit of popular managing director Narayanan Govindarajan.

ANI Pharmaceuticals has completed its acquisition of niche generics specialist Novitium Pharma, securing access to a pipeline of generics and 505(b)(2) candidates that has expanded further since the deal was announced earlier in the year.