Biosimilars
Spectroscopy remains dominant when investigating biosimilar structures
Biopharmacological studies, including biosimilar studies, require investigation of the higher order structure of proteins. A recent review published in GaBI Journal (GABIJ) [1] has found that, although many analytical methods to determine the higher order structures exist, spectroscopic methods remain the most used.
Cadila launches two new similar biologics in India
Cadila Pharmaceuticals (Cadila) has launched two similar biologics onto the Indian market: NuPTH, a teriparatide similar biologic and Cadalimab, a similar biologic of the auto-immune treatment adalimumab. Cadila has launched four new products on the domestic market since July 2020.
Biocon and Celltrion make progress in the battle against COVID-19
Biocon has reported promising results from a clinical trial of its biosimilar itolizumab in patients hospitalised with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. Meanwhile, Celltrion Healthcare (Celltrion) is investigating the use of its infliximab biosimilar CT-P13 to treat patients with COVID-19 infection.
Sustainable market scorecard represents gold-standard for biosimilar sustainability
IQVIA Institute and Medicines for Europe have recently launched Country Scorecards for Biosimilar Sustainability in 12 European countries [1]. The scorecards assess the level of competition, price evolution and volume development for seven key biological molecules – adalimumab, etanercept, infliximab, insulin glargine, insulin lispro, rituximab and trastuzumab – in each country. They also present a sustainability assessment and detail positive policy elements, challenges and solutions for each country.
Phase III trial updates of Samsung Bioepis’ bevacizumab and aflibercept biosimilars
Samsung Bioepis has reported positive results from a phase III trial of its bevacizumab biosimilar, Aybinto. The company is also initiating a phase III trial for its aflibercept biosimilar, SB15.
Indications expanded for Merck’s etanercept biosimilar Brenzys
The indications of Merck Canada’s etanercept biosimilar Brenzys have been expanded to include plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis.
FDA to investigate PD biomarkers to show biosimilarity
The US Food and Drug Administration (US FDA) is conducting research on critical aspects of the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. A study published in Clinical Pharmacology and Therapeutics, has outlined how the agency hopes to inform their thinking on critical aspects of how these biomarkers can be used to reduce the need for comparative clinical studies [1]. In turn, this can reduce the time and cost of bringing a biosimilar product to market, giving faster access to affordable, safe, and effective treatments.
FDA updates Purple Book database
The US Food and Drug Administration (FDA) has updated its searchable Purple Book database to include allergenic, cellular and gene therapy, haematologic and vaccine products.
Insulin glargine biosimilar Semglee launched in US
The partnership of US-based drugmaker Mylan and Indian biologicals specialist Biocon announced on 31 August 2020 the launch of their insulin glargine product, Semglee, in the US.
Biosimilars allow fast access to biological drug therapy in Bavaria, Germany
A new study has shown that patients suffering from rheumatism in Bavaria, Germany, are now likely to be prescribed a biological medicine much faster than five years ago. Results of the study were shared at the AG Pro Biosimilars digital symposium on 14 September 2020.
