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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 ...

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 settleme...

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, ...

Sandoz announced that the EMA has accepted its application for high concentration (100mg/mL) citrate-free product Hyrimoz® (biosimilar adalimumab).  Sandoz’s application seeks approval for all AbbVie Humira® indications.

Alvotech announced that its shares and warrants began trading on the Nasdaq on 16 June under the new ticker symbols ‘ALVO’ and ‘ALVOW’ respectively, following the completion of the company’s business combination with Oaktree Acquisition Corp. II.  The transaction was suppor...

Innovent Biologics and PT Etana Biotechnologies announced that the Indonesian Food and Drugs Authority has approved Bevagen® (bevacizumab biosimilar) for metastatic colorectal cancer (mCRC); locally recurrent or metastatic triple negative breast cancer (mTNBC); advanced, me...

MSD announced that the FDA has accepted its sBLA for Keytruda® (pembrolizumab) as adjuvant therapy for stage IB-IIA non-small cell lung cancer following complete surgical resection.