Shots: Kamada signs an agreement with two undisclosed international pharmacies to commercialize three biosimilar product candidates in Israel. The two pharmaceutical companies will be responsible for the development, manufacturing, and supply of three products Following the approval from EMA and IMOH, the three products are expected to be launched in Israel b/w 2022 and 2024 […]
Shots: The EMA Submission is based on P-l CHRYSALIS study to evaluate the safety and efficacy of Amivantamab as a monotherapy and in combination with Lazertinib in adult patients for the treatment of advanced NSCLC Result of CHRYSALIS Study assessed efficacy using overall response rate per Response Evaluation Criteria, CBR, DOR and PFS as well […]Read More
Shots: Cullinan will receive $20M up front and is eligible to receive ~$211M in development, regulatory and sales-based milestone payments Cullinan is also eligible for high-single-digit to low-teen tiered royalties based on sales of CLN-081 in Greater China includes Hong Kong, Macau and Taiwan CLN-081 is an orally available, small-molecule, irreversible EGFR inhibitor, which is […]Read More
Shots: The approval is granted in pediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis in adults, who do not respond adequately to corticosteroids. These are fifth and sixth approved indications of Sulinno in China and it was first approved by NMPA on Sep 2, 2020 Sulinno is an adalimumab biosimilar which is […]Read More
Shots: The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in 256 patients in a ratio (1:1) with grade 1, 2, or 3a follicular B-cell NHL & low tumor burden The WAC of Riabni will be 23.7% lower than the Rituxan […]Read More
Shots: Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as reference Humira, including rheumatology, gastroenterology and dermatology A patient support program will be available to patients treated with Hyrimoz providing guidance with reimbursement navigation, financial assistance, administrative support & education […]Read More
Shots: The P-lll study will assess the efficacy, safety, pharmacokinetics PK/PD, and immunogenicity of SB16 vs Prolia in 432 female volunteers for postmenopausal osteoporosis The company has initiated the P-I study to compare the PK/PD, safety, tolerability, and immunogenicity b/w SB16 and Prolia in healthy volunteers in Oct’2020 Samsung Bioepis has three biosimilar candidates – […]Read More
Shots: The agreement strengthens the ongoing collaboration b/w the companies signed in 2018 to commercialize Alvotech’s biosimilar portfolio in Japan Fuji Pharma currently owns a minority stake in Alvotech and now can enter new therapeutic areas following the agreement With the extension of the agreement, Fuji Pharma has a leading biosimilar pipeline in Japan. Fuji […]Read More
Shots: The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma […]Read More
Shots: The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China while Yangtze River Pharmaceutical will exclusively commercialize the biosimilars […]Read More
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