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.”

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.

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.

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.

A provision in the pending legislation on PBMs that would allow the US FDA to provide qualitative and quantitative information to ANDA sponsors about reference product's inactive ingredients could save hundreds of millions in spending.

With multiple generic molecules experiencing treble-digit-percentage price increases in the UK in August, betahistine tablets led the month’s biggest risers, according to WaveData.

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.

After a couple of years of heavy downwards pressure on US generics prices, prominent off-patent companies have pointed to a change in the pricing environment as several factors combine to reduce price erosion. Meanwhile, some firms are benefiting from first generic launches as others exit the market altogether, while injectables shortages continue to loom large.

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.

Teva potentially was only a matter of days away from hearing a decision in its patent litigation battle over Vivitrol (naltrexone) long-acting injectable, but has instead put pen to paper on a settlement deal.

The Brazilian medicines regulator, ANVISA, is considering whether to allow generic drug labeling to omit indications of the originator product that are still under patent. "Skinny labels" also figure in an ongoing court case involving Boehringer Ingelheim's Ofev (nintedanib).

Sun is looking to reignite Orexo’s legal headaches over its key Zubsolv opioid dependence treatment, following the Indian firm’s defeat in patent-litigation proceedings last month.

With multiple generic molecules experiencing treble-digit-percentage price increases in the UK in August, betahistine tablets led the month’s biggest risers, according to WaveData.

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.

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.

After a couple of years of heavy downwards pressure on US generics prices, prominent off-patent companies have pointed to a change in the pricing environment as several factors combine to reduce price erosion. Meanwhile, some firms are benefiting from first generic launches as others exit the market altogether, while injectables shortages continue to loom large.