Business

Biosimilars Check-In: Celltrion Pushes for Yuflyma in Europe; Xbrane Updates on Ranibizumab Filing

July 21st 2022

By Skylar Jeremias

In recent weeks, Celltrion Healthcare furthered its adalimumab biosimilar (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.

Alvotech to Launch Pharmacokinetics Study for Denosumab Biosimilar

July 20th 2022

By Mary Caffrey

Article

The biosimilar candidate would reference Prolia, used in the treatment of osteoporosis in postmenopausal women and to treat bone loss in adult men and women who are at increased risk of fracture. It is also planned as a biosimilar for Xgeva, which is indicated to prevent skeletal fractures in patients with cancer.

Report: Biosimilar Uptake Accelerates in US—and So Do the Savings

July 13th 2022

By Mary Caffrey

Article

Amgen's early view said health care savings from the use of these biologic therapies climbed to $3 billion in the second quarter of 2022, for total of $18 billion over the past 6 years.

Biosimilars Business Roundup: June 2022

June 30th 2022

By Skylar Jeremias

Article

June brought with it several updates for biosimilars and the companies that make them, including the US launch of the first ranibizumab biosimilar, a new partnership between Organon and Shanghai Henlius Biotech, and the announcement of Sandoz’ global biosimilar initiative.

Henlius Begins Phase 3 Trials for Denosumab Biosimilar

June 29th 2022

By Skylar Jeremias

Article

Shanghai Henlius Biotech announced the commencement of a phase 3 trial for its denosumab biosimilar (HLX14) referencing Xgeva in postmenopausal patients with osteoporosis with a high risk of fracture.

CHMP Gives Thumbs Up for Celltrion, Formycon Biosimilars

June 25th 2022

By Skylar Jeremias

Article

The European Committee for Medicinal Products for Human Use (CHMP) recommended 2 biosimilars for approval: Celltrion Healthcare’s bevacizumab candidate and Formycon’s prospective ranibizumab product.

Formycon: Biosimilar Acquisitions, Developments Signal Hope Despite Losses

June 23rd 2022

By Skylar Jeremias

Article

Formycon’s completed acquisition of 2 biosimilar assets and start of development for 2 others provide hope for investors as the company announced some expected losses during the first quarter of fiscal year 2022.

After Announcing Global Biosimilar Initiative, Sandoz Sees EU Biosimilar Application Acceptance

June 20th 2022

By Skylar Jeremias

Article

Not long after the company announced its new global initiative to promote access and increase adoption of biosimilars, Sandoz’ biologics license application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.

Study: Financial Viability of Biosimilars Depends on Originator Sales, Market Entry Order

June 18th 2022

By Deana Ferreri, PhD

Article

A financial evaluation study proposed a framework for choosing which biosimilar candidates companies should develop, a process that requires a detailed and careful analysis to ensure that the candidate will be successful in global biopharmaceutical markets.

Public Trading on Alvotech Shares Begins Globally

June 15th 2022

By Skylar Jeremias

Article

Iceland-based Alvotech announced that the pureplay biosimilars company is debuting on the public market starting June 16.