BioBlast® w/e 24 Jun 22: Alvotech dual NASDAQ listing, Samsung Bioepis/Samil ranibizumab, Formycon Q1/22 results, Daiichi Sankyo trastuzumab deruxtecan, Midas Pharma’s ranibizumab, Celltrion’s bevacizumab, Merck’s pembrolizumab, AVEO/Eli Lilly agreement, Innovent’s sintilimab

by , | Jun 27, 2022

20 Jun 22 | CN | NMPA approves Innovent’s TYVYT® (sintilimab injection)

Innovent Biologics and Eli Lilly announced that the CDE of China’s NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination with cisplatin plus paclitaxel or cisplatin plus 5-FU chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

21 Jun 22 | KR | Samsung Bioepis and Samil sign ranibizumab commercialisation agreement

Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical have signed a commercialisation agreement for Amelivu®,biosimilar to Lucentis® (ranibizumab).  Under the agreement, Samil is licenced to sell Amelivu® in Korea.  Samsung Bioepis signed a settlement with Genentech in 2021 allowing it to market its ranibizumab biosimilar from June 2022.  Amelivu®/Byooviz® has been approved in the EU, US, Canada and Korea, and was launched in the US in June 2022.

21 Jun 22 | Formycon publishes Q1/22 financial results

Formycon published its Q1 2022 financial results, reporting sales and other earnings of EUR 8.2 million.  Formycon also announced the addition of two biosimilar projects to its pipeline, FYB208 and FYB209, for undisclosed products.  Late stage Formycon development programs include biosimilars to Lucentis® (ranibizumab), Stelara® (ustekinumab) and Eylea® (aflibercept). Formycon plans to launch its biosimilar to Lucentis® (ranibizumab) in the second half of 2022.

22 Jun 22 | Alvotech becomes first dual-listed Icelandic company

Following its 16 June 2022 listing of warrants and shares on the NASDAQ Alvotech debuted on the NASDAQ First North growth market on 23 June 2022, becoming the first dual US-Icelandic listed company.  Alvotech’s current portfolio of eight products and product candidates represent an estimated total addressable market of over US$85 billion, based on estimated peak sales of the reference products.

Alvotech’s portfolio includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; aflibercept/biosimilar to Eylea®, denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.

Alvotech has signed commercialisation agreements with CiplaStadaFuji Pharma, BiosanaPharma, Teva, JAMP/BIOJAMP, DKSH and Yangtze River Pharmaceuticals.

22 Jun 22 | AVEO Oncology and Eli Lilly enter into agreement for ficlatuzumab and cetuximab

AVEO Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Eli Lilly to evaluate ficlatuzumab in combination with ERBITUX® (cetuximab) in the US and Canada in patients with recurrent or metastatic head and neck squamous cell carcinoma.  This follows a similar engagement with Merck earlier in 2022 regarding Aveo’s clinical development plan for ficlatuzumab.

24 Jun 22 | EU | CHMP recommends change to indication for Daiichi’s Enhertu® (trastuzumab deruxtecan)

EU’s CHMP adopted a positive opinion recommending a change to the existing indication for Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) to ‘Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two one or more prior anti HER2 based regimens’.

23 Jun 22 | EU | CHMP recommends approval of Midas’ Ranivisio® (ranibizumab/biosimilar to Lucentis®)

The CHMP recommended the approval of Midas Pharma’s 10mg/ml Ranivisio® (ranibizumab/biosimilar to Lucentis®) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema or choroidal neovascularisation, and proliferative diabetic retinopathy.

23 Jun 22 | EU | CHMP recommends approval of Celltrion’s Vegzelma® (bevacizumab/biosimilar to Avastin®)

The CHMP recommended the approval of Celltrion’s Vegzelma® (bevacizumab/biosimilar to Avastin®) for the treatment of 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.

24 Jun 22 | EU | EC approves additional indications for Merck’s Keytruda® (pembrolizumab)

Merck announced that the EC has approved Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection, as well as expanding the indications for Keytruda® in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) in adolescent patients aged 12 years and older.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

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