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Henlius to present new studies on serplulimab (anti-PD-1 mAb) and HLX04 (bevacizumab biosimilar)
Henlius announced that it will present the results of new studies on serplulimab (anti-PD-1 mAb) and HLX04 (bevacizumab biosimilar) at the 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO).
CA |EU |US | Bio-Thera Solutions and Sandoz enter into agreement for bevacizumab biosimilar
Bio-Thera Solutions announced that it has entered into a commercialisation and license agreement with Sandoz to commercialise BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Sandoz will commercialise the product in the US, Europe, Canada and other international markets in exchange for an upfront payment, potential milestone payments and royalties on product sales.
AU | Australia’s TGA approves Mylan/Alphapharm’s Abevmy® (biosimilar bevacizumab)
Australia’s TGA approved Mylan/Alphapharm’s Abevmy® (biosimilar bevacizumab) for the treatment of colorectal cancer, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube, peritoneal cancer and cervical cancer.
Outlook Therapeutics reports positive data from Ph III trials of bevacizumab biosimilar
Outlook Therapeutics reported positive efficacy and safety data from Ph III trials of ONS-5010 (proposed bevacizumab biosimilar) for the treatment of neovascular age-related macular degeneration.
Amgen released its Q2 2021 financial results
Amgen released its Q2 2021 financial results, reporting double digit volume growth for Prolia® (denosumab), Repatha® (evolocumab), Mvasi® (biosimilar bevacizumab) and Kanjinti® (biosimilar trastuzumab).
American Academy of Ophthalmology pushed back against pressure to use bevacizumab biosimilars off-label
The American Academy of Ophthalmology pushed back against insurance company pressure to use new bevacizumab biosimilars off-label in eye treatment as alternatives to Avastin® (bevacizumab) in the absence of supporting studies.
Shanghai Henlius Biotech doses first patient in Ph I bevacizumab trials
Shanghai Henlius Biotech announced that the first patient has been dosed in its Ph I clinical trial of HLX04-O (proposed bevacizumab biosimilar) in the treatment of wet age-related macular degeneration.
AU | AU’s PBAC recommends listing Mvasi, Keytruda and Stelara
Australia’s PBAC recommended the listing of Amgen’s Mvasi® (biosimilar bevacizumab). The PBAC also recommended listing Keytruda® (pembrolizumab) for the first line treatment of unresectable or metastatic mismatch repair deficient colorectal cancer and recommended listing Stelara® (ustekinumab) for the treatment of paediatric patients with severe chronic plaque psoriasis.
New data on Luye Pharmaceuticals’ proposed bevacizumab biosimilar published
A new study published in Cancer Communications concluded that Luye Pharmaceuticals’ LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to reference Avastin® in terms of efficacy and safety in patients with advanced or recurrent non-squamous non-small cell lung cancer
CN | NMPA approves sNDA for Tyvyt® (sintilimab) in combination with Byvasda® (biosimilar bevacizumab)
Innovent Biologics announced China’s National Medical Products Administration has approved its supplemental New Drug Application for Tyvyt® (sintilimab) in combination with Byvasda® (biosimilar bevacizumab) as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma.
US | FDA accepts BLA for Amneal’s proposed bevacizumab biosimilar
Amneal announced the FDA has accepted the BLA for Alymsys™ (proposed bevacizumab biosimilar). Alymsys™ was developed in collaboration with mAbxience.
Celltrion reports Q1 2021 financial results
Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%. Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, omalizumab and denosumab candidates remain in Ph III trials.
Merck reports its vision for Organon
Merck reported the vision, focus and business model for its new standalone company, Organon. Merck disclosed that Organon with have a direct sales presence in 58 markets, with key growth drivers in Organon’s biosimilars portfolio expected to be Renflexis® (biosimilar infliximab), Aybintio® (biosimilar bevacizumab) and Hadlima® (biosimilar adalimumab).
EU | Biocon receives EC authorisation for Abevmy® (biosimilar bevacizumab)
AU | PBAC publishes March outcomes
Australia’s PBAC published the outcomes of its March 2021 meeting. The recommendations include:
- Mvasi® (Amgen’s biosimilar bevacizumab): the PBS listing has been changed to an unrestricted benefit to allow access to combination treatment with atezolizumab.
- Beovu® (brolucizumab): Beovu® was recommended for subfoveal choroidal neovascularisation due to AMD.
- Keytruda® (pembrolizumab): PBAC recommended Section 100 Authority Required listing for the treatment of metastatic colorectal cancer.
Roche published Q1 2021 earnings report
Roche published its Q1 2021 earnings report, noting significant impacts from biosimilars. In particular, Roche attributed a combined sales reduction of CHF 1.6 billion to the impact of rituximab, bevacizumab and trastuzumab biosimilars.
CN | NMPA accepts Luye Pharma’s bevacizumab application
Luye Pharma announced its marketing authorisation application for LY01008 (proposed bevacizumab biosimilar) has been accepted by China’s National Medical Products Administration.
RU | Prestige Biopharma and Pharmapark reach biosimilar bevacizumab deal
Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.
EU | STADA launches Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany
STADA launched Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany. Oyavas® is indicated for carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
EU | CHMP recommends listing Biocon’s Abevmy®(biosimilar bevacizumab)
Biocon and Viatris announced that the CHMP has adopted a positive opinion recommending the marking authorisation of Abevmy® (biosimilar bevacizumab). If approved, Abevmy® will be available for the treatment of metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer in 100mg and 400mg injections. The decision of the EC is expected in May 2021.
Roche reports huge erosion of YoY CER growth in key areas
Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 franchise (including trastuzumab and pertuzumab) at -8%.
EU | CHMP recommends 13 medicines for approval
The CHMP recommends13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.
US | FDA accepts BLA for Bio-Thera’s biosimilar bevacizumab
Innovent signs bevacizumab deal
Innovent announces it has signed a licensing agreement with PT Etana Biotechnologies for Byvasda® (biosimilar bevacizumab). Under the agreement, Etana will receive commercialisation rights in Indonesia in exchange for milestone payments and double-digit royalties on net sales.
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
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