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The company has introduced SC formulation of Tyenne, a biosimilar of Actemra, to treat chronic autoimmune diseases across the US. It is available in the form of prefilled syringe & an autoinjector
The IV formulation of the biosimilar was introduced in Apr 2024 after the US FDA’s approval on Mar 05, 2024
Tyenne, an…
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The US FDA approved Fresenius’ Tyenne (tocilizumab-aazg) developed as a biosimilar version of Actemra (tocilizumab)
According to the patent settlement agreement signed between Fresenius Kabi and Genentech for Tyenne, Fresenius has the license to market its tocilizumab products across the US as per the undisclosed licensing dates
Tyenne functions as an Interleukin-6 (IL-6) receptor…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
During the month of September, Sandoz entered into a development and commercialization agreement…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
During the month of August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of July, Samsung Bioepis reported P-III equivalence study…
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of February, Alvotech entered into a commercialization agreement…
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The US FDA approved 8 NDAs and 5 BLA in December 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 86 novel products in 2022
In December 2022, the major highlights drugs were Krazati (adagrasib) approval for non-small cell lung cancer with a KRASG12C mutation, Sunlenca…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of December, Alvotech and STADA launched Hukyndra (biosimilar, adalimumab)…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of September, Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) received the…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of August, Formycon reported P-III (VESPUCCI) trial results of…

