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Pearce IP BioBlast®: w/e 22 October 2021

by | Oct 26, 2021

14 Oct 21 | Gan & Lee Pharmaceuticals announced the completion of two Ph III studies of its proposed insulin glargine biosimilar.

15 Oct 21 | US | Roche announced that the FDA has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer whose tumours express PD-L1≥1%.

16 Oct 21 | Bio-Thera Solutions announced it has reached a licensing and supply agreement with Pharmapark for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Pharmapark will have exclusive rights to distribute and market the product in Russia and other CIS countries.

18 Oct 21 | AU | Australia’s TGA provisionally approved Roche’s Ronapreve™ (casirivimab and imdevimab) for two indications relating to COVID-19. Ronapreve™ is indicated for the treatment of COVID-19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19, and for the prevention of COVID-19 in adults and adolescents who have been exposed to SARS-CoV-2 and who either have a medical condition making them unlikely to respond to or to be protected by vaccination or are not vaccinated against COVID-19.

19 Oct 21 | AU | Opthea announced that the first clinical trial sites in the Asia-Pacific region are now open for patient enrolment in its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor).

20 Oct 21 | HepaRegeniX announced a new collaboration with the Netherlands Cancer Institute to investigate HRX-0233 (MKK4 inhibitor candidate) in preclinical in vivo models with Kirsten rat sarcoma virus (KRAS) mutant tumours.

20 Oct 21 | US | Samsung Bioepis announced that the FDA has approved Byooviz™ (ranibizumab biosimilar) for the treatment of neovascular age-related macular degeneration, macular edema and myopic choroidal neovascularisation.

20 Oct 21 | MorphoSys announced that the first patient has been dosed in its Ph II trials evaluating felzartamab for patients with Immunoglobulin A Nephropathy.

21 Oct 21 | US | Biocon announced that pharmacy benefit management company Express Scripts will list Semglee® (interchangeable biosimilar insulin glargine) as a preferred insulin brand on its National Preferred Formulary.

21 Oct 21 | AU | The NSW State Government pledged $96 million towards a RNA pilot manufacturing facility, to be established in partnership with NSW universities. The facility is expected to house laboratories and pre-clinical trial spaces to enable early-stage RNA-based drug development.

21 Oct 21 | CN | Kintor Pharmaceutical announced that China’s NMPA has approved clinical trials for GT90008 (PD-L1/TGF-β dual-targeting antibody) for the treatment of advanced solid tumours.

21 Oct 21 | EU | BMS announced that the EMA has approved Opdivo® (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

22 Oct 21 | US | Genentech announced that the FDA has approved Susvimo™ (ranibizumab) for intravitreal use via ocular implant for the treatment of patients with wet age-related macular degeneration who have previously responded to at least two anti-VEGF injections.

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