Shots: Generic medicines play a pivotal role in offering cost-effective alternatives to high-priced pharmaceuticals. They often serve as a critical lifeline in developing and underdeveloped nations, helping to address both chronic and infectious diseases. In 2024, the global generics market was valued at $445.62B, with projections to reach approximately $468.08B in 2025 and ~$728.64B by…
Shots:The US FDA has approved Enoby (RGB-14-P) & Xtrenbo (RGB-14-X), biosimilar versions of Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disordersApproval was based on extensive clinical data submitted by Hikma, incl. analytical, non-clinical & clinical studies, which showed comparable quality, efficacy, safety & immunogenicity of Enoby & Xtrenbo to reference…
Shots:The EC has approved Usymro (BAT2206), a biosimilar version of J&J’s Stelara (ustekinumab) for all indications of the reference productIn Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU,…
Shots:The CHMP has recommended Usymro (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference productOpinion was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK &…
Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva)
Shots: The CHMP has recommended marketing authorization for Junod and Yaxwer, biosimilars of Amgen’s Xgeva & Prolia (denosumab) Denosumab is approved to treat postmenopausal osteoporosis, prevent bone complications from cancer metastases, and treat unresectable giant cell tumors of bone Junod & Yaxwer are mAbs (IgG2) that block RANKL, preventing osteoclast activation Ref: Gedeon Richter | Image: Gedeon Richter…
Biosimilars are the key alternatives for expensive Biologics therapies and saving millions of dollars of patients spent in the treatment of multiple diseases. Hence physicians are likely to adopt biosimilars a reference product to biologics possessing similar therapeutic properties in terms of potency- safety- and efficacy to original biologic products. The companies are focusing…
Biosimilars are key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars a reference product to biologics possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of biosimilar space…

