Safe Biologics
SEPTEMBER 27, 2024
Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic. Biosimilars offer new treatment choices and more price competition, increasing access and affordability for patients. But the safeguards physicians count on may soon be removed.
Pharmaceutical Business Review
NOVEMBER 11, 2024
” Founded in 2008, Alteogen specialises in developing biologics, including ADCs, biobetters, and biosimilars. The company’s portfolio comprises clinical-stage long-acting therapeutic proteins and next-generation ADCs developed through its platform technologies, NexP-fusion and NexMab.
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pharmaphorum
JULY 21, 2022
The appointment might raise some eyebrows given Roche’s need to drive pharma sales as it copes with the loss of patent protection on an earlier generation of antibody-based therapies – now being hit by biosimilar competition – but Schwan is confident Schinecker is the right man to lead the company forward.
Express Pharma
SEPTEMBER 6, 2023
In a bid to resolve both physical and financial restrictions inhibiting equitable access to quality medicines, the Jan Aushadhi scheme was launched in 2008 and envisaged the setting up of dedicated Janaushadhi Kendras to provide quality generic medicines at capped prices for the general public. appeared first on Express Pharma.
FDA Law Blog: Biosimilars
NOVEMBER 27, 2023
Walsh — Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to “protect the public against unreasonable risks of injury associated with consumer products,” it was not until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) to impose criminal liability against individual directors, (..)
FDA Law Blog: Biosimilars
APRIL 30, 2023
110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. 112-144 (2012).
PharmaState Academy
MAY 16, 2023
Over the next 15 to 20 years, you can expect pharma business models of today to be metamorphosed by biopharmaceuticals and biosimilars. The value of Biologics (2008), pp. Medical representatives will have to transform into knowledge workers and their upline too will have a redefined leadership role to play.
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