Following the formation of their partnership nearly five years ago, Alvotech and Fuji have together welcomed approval in Japan for Alvotech’s biosimilar to Stelara (ustekinumab).

Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.

BioFactura has completed a successful Phase I trial of its Stelara (ustekinumab) biosimilar BFI-751, which is expected to file in developed markets in 2026.

European biosimilars specialist mAbxience will hand several of its biosimilars over to the global commercialization expertise of Abbott under a new agreement signed between the firms.

Glenmark Pharmaceuticals has divested its API arm to the Nirma group for over $681m, a move that will deleverage the drug maker’s balance sheet as it seeks to evolve into an “innovative/brand led organization.”

Japanese originator Takeda has agreed to settle two-year-old anticompetitive claims lodged by wholesalers in the US that it conspired with several generics manufacturers to maintain supracompetitive pricing for its Colcrys branded treatment for gout.

European biosimilars specialist mAbxience will hand several of its biosimilars over to the global commercialization expertise of Abbott under a new agreement signed between the firms.

The FTC’s proposed consent order allowing Amgen to move ahead with its mammoth takeover of Horizon includes an interesting stipulation for industry – one involving biosimilars.

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

Glenmark Pharmaceuticals has divested its API arm to the Nirma group for over $681m, a move that will deleverage the drug maker’s balance sheet as it seeks to evolve into an “innovative/brand led organization.”

Alvotech has revealed a US FDA goal date of 24 February 2024 for its refiled AVT02 proposed high-concentration interchangeable adalimumab biosimilar rival to Humira, as the firm provided further details of the resubmission – including an expected facility reinspection.

Adcock saw its profits grow by 4.2% during FY 2024 despite a challenging economic environment.

Analysts posted wary notes about the prospects of South African pharmaceutical firm Aspen as its financial year came to an end, while management maintained confidence in the firm’s “solid results.”

India’s Glenmark is hoping that its proposed generic version of GlaxoSmithKline’s Flovent will benefit from a limited competition market, as it continues to plan a filing with the US Food and Drug Administration.

Swedish biosimilars player Xbrane spoke candidly about its recent launch of the company’s first product, the Stada-partnered Ximluci biosimilar to Lucentis in Europe, as it updated on the company’s ongoing hunt for a new US commercialization partner.

Biocon has named Peter Bains as its new group CEO, as the firm’s Biocon Biologics business confirmed that its aflibercept biosimilar to Eylea had become the first to receive a formal European approval.

Alvotech has appointed a fresh chief operating officer as it continues to pursue a US approval for its adalimumab biosimilar. Meanwhile, Strides Pharma Science’s strategy head has left the company and Nick Haggar has joined Biocon’s board, while US association the AAM has also welcomed new staff.

As it continues to build on the biosimilars business gained from a major transaction with former partner Viatris, Biocon Biologics has announced a raft of executive appointments to bolster its management team.

After a tough 2022 for its generics business, Hikma is predicting big things for the division this year, raising its full-year guidance from 20% growth to nearly 30% as new CEO Riad Mishlawi prepares to take the reins from the start of September. Meanwhile, the firm has also picked up assets from Akorn following its collapse.