Strategy

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.

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.

At an extraordinary general meeting held earlier today, Novartis shareholders gave the go-ahead for the spinoff of the Sandoz generics and biosimilars business, paving the way for a formal separation on 4 October.

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.”

Biocon’s ongoing legal battle with Regeneron over US patents shielding Eylea was discussed by the originator at a pair of recent healthcare conferences, with a decision due any day.

After launching the Uzedy long-acting formulation of risperidone in partnership with MedinCell earlier this year, Teva has stressed the “really exciting” product profile of another long-acting antipsychotic from the partnership, olanzapine, while discussing how it will avoid the safety pitfalls of legacy products in the space.

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.

As Biocon Biologics completes its integration of the biosimilars front-end business that it acquired from former partner Viatris, Biocon founder and chairperson Kiran Mazumdar-Shaw talks to Generics Bulletin about how the firm is now capturing the full value of its biosimilars, while also looking at expanding into new markets previously unserved by Viatris.

Sandoz has filled a gap in its biosimilars pipeline by in-licensing Samsung Bioepis’ SB17 ustekinumab biosimilar to Stelara, for commercialization in multiple global markets.

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.

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.

Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.

After PEs, Torrent Pharma is speculated to be in the fray for a stake in Cipla. Experts weigh in on the contours of the product and cultural alignment of the two firms, should things move forward and also whether other Indian players could take a shot at the 'once in a lifetime opportunity'.