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Teva
NEWS

Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA 

Shots:  The US FDA and the EMA has accepted Teva’s applications for TVB-009P, biosimilar version of Prolia (denosumab), for all the approved indications, with their decisions anticipated during H2’25  Submissions were built upon the data from P-III (TVB009-IMB-30085) study assessing safety & efficacy of TVB-009P vs Prolia among women with postmenopausal osteoporosis as well as…
October 8, 2024

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NEWS

GlycoNex Reports the Completion of P-I Study Assessing SPD8 (Biosimilar, Prolia) for Osteoporosis 

  Shots:  GlycoNex, in partnership with Mitsubishi Gas Chemical Company, has concluded the P-I trial assessing SPD8, biosimilar version of Prolia (denosumab), for treating osteoporosis. Both the companies have completed the P-I study across Japan  Based on these results, SPD8 will proceed to P-III trial aimed at assessing its efficacy, safety & immunogenicity among larger…
August 19, 2024

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NEWS

Alvotech and STADA Extend their Strategic Partnership Covering AVT03 (Biosimilar, Denosumab) 

Shots:  Alvotech & STADA expand their strategic collaboration covering AVT03, biosimilar of Prolia/Xgeva (denosumab), to treat osteoporosis & cancer-related bone loss, respectively  As per the agreement, AVT03 will be developed & manufactured by Alvotech at its state-of-the-art facility while STADA becomes marketing authorization holder with semi-exclusive commercial rights across the EU, incl. Switzerland & the…
June 11, 2024

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Fresenius Kabi
NEWS

Fresenius Reports the US FDA’s BLA Acceptance of FKS518 (Biosimilar, Denosumab) 

The US FDA has accepted the BLA of the company’s FKS518, a biosimilar product of Prolia (denosumab) and Xgeva (denosumab)  The BLA was supported by the analytical development & similarity evaluation data from two trials comparing FKS518’s pharmacokinetic profile in one while efficacy and safety in another study with the reference  FKS518 is indicated for…
May 27, 2024

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NEWS

Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China 

Shots:  The NMPA approved Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg), an anti-RANKL mAb, to treat unresectable giant cell tumors of the bone or resectable’s which may lead to severe functional impairment  Maiweijian vs XGEVA (original product) has shown similarity in PK, PD, clinical efficacy and safety in patients with solid tumor bone metastases  The P-I &…
April 3, 2024

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NEWS

Mabwell Highlights Results from the P-III Study of MW032 (biosimilar, denosumab) for Solid Tumors in JAMA Oncology 

Shots:  The results from the P-III trial comparing MW032’s (SC, Q4W, until wk. 49) safety, efficacy & PK vs reference drug (denosumab) to treat patients (n=708), randomized 1:1, with solid tumors having bone metastasis are published in JAMA Oncology  The 1EP includes percentage change in natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr) from baseline to…
February 19, 2024

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Disease of the Month- Osteoporosis
INSIGHTS+

Disease of the Month- Osteoporosis

To keep our readers acquainted with several disease conditions, ongoing trials, and available treatment options, PharmaShots brings every month a detailed take on a particular disease after thorough research   Continuing the series for the disease of the month, PharmaShots brings a condensed report on Osteoporosis, a bone and tissue disorder  October 20th is observed as…
October 12, 2023

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