Significant biosimilar activities this week include
14 Sep 20 | Novartis announced the results of Ph III trials of Beovu® (brolucizumab) in diabetic macular edema. Novartis announced the trial met its primary and key secondary endpoints, demonstrating non-inferiority of Beovu® versus aflibercept at year one.
14 Sep 20 | US | Republican Congressman Glenn Grothman introduced a bill to waive interchangeability requirements for FDA approved insulin products. If passed, this bill would allow for insulin products to be automatically substituted at the pharmacy counter at the patient and physician’s discretion.
15 Sep 20 | CA | Merck announced Health Canada has approved Brenzys® (biosimilar etanercept) for four new indications:
- adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy
- pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy
- reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis and improving physical function in adult patients with psoriatic arthritis (PsA)
- reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years
15 Sep 20 | Samsung Bioepis announced the results of Ph III trials of Aybintio® (biosimilar bevacizumab) reinforce the equivalent clinical efficacy between Aybintio® and the reference product. The results will be presented for the first time at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
15 Sep 20 | EU | Mylan announced the European Commission has approved the proposed merger between Mylan and Pfizer’s Upjohn. Following approvals in Australia and New Zealand, clearance is only pending in the US. Mylan announced that they expect the transaction will be closed in Q4 2020. The merger NewCo now know as “Viatris” will provide expanded reach for (Mylan) biosimilars including trastuzumab (Ogivri®), bevacizumab (Abevmy®), pegfilgrastim (Fulphila®), and insulin glargine (Semglee®) together with pipeline products including biosimilars to abatacept and aflibercept.
17 Sep 20 | Lotus Pharma announced it has signed a commercialisation agreement with Chong Kun Dang for Nesbell® (biosimilar darbepoetin-alpha). Under the agreement, Chong Kun Dang will supply Lotus with Nesbell® for sale in Taiwan, Vietnam and Thailand pending the success of clinical trials in those countries.
17 Sep 20 | The Centre for Biosimilars reported that data presented at the ESMO Virtual Congress by PrestigeBiopharma demonstrates positive findings for Ph I trials of HD201 (proposed trastuzumab biosimilar). HD201 is current under review by the EMA.