Development

Although India is far ahead of other countries in terms of biosimilar approvals, its regulatory structure may hinder efforts for international sales.
 
Roman Drai, MD, PhD, deputy director and head of clinical operations at Geropharm, discussed Geropharm’s budding biosimilar pipeline and the company’s international pursuits during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.
Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence for biosimilars.
Interest in tocilizumab has grown lately as Roche has a clinical trial underway to evaluate efficacy in coronavirus disease 2019 (COVID-19)–related pneumonia.
Samsung Bioepis isn't flinching on its trastuzumab biosimilar launch schedule, COVID-19 and 4 other biosimilar competitors notwithstanding, said Sang-Jin Pak, MD, executive vice president of the company's Commercial Division.
With positive phase 1 study results and a manufacturing process that may cut costs significantly, BiosanaPharma hopes its omalizumab biosimilar candidate will have an edge on the worldwide market.
 
Even as the first bevacizumab biosimilar gained approval for marketing in China, data emerged from a phase 1 pharmacokinetic study comparing the biosimilar with its reference product (Avastin).  
The study compared the stool samples of patients with ulcerative colitis (UC) with patients with familial adenomatous polyposis. Both groups may have colectomies, but only the patients with UC have inflammation that may return even after surgery.
Sarfaraz K. Niazi, PhD, a pharma industry veteran and consultant for biosimilar makers, discusses ins and outs of the approvals process that cause frustration and unnecessary expense.
The study examined secukinumab biosimilar lentivirus-based gene therapy, which showed successful and prolonged expression of the recombinant antibody in rats.

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