Mylan and Biocon have received a complete response letter for a version of Amgen’s Neulasta (pegfilgrastim) in the latest regulatory blow to their biosimilar ambition.
ChromaTan will develop an integrated and continuous downstream purification platform through provisions in the 21st Century Cures Act to support manufacturing initiatives.
An increase of quality, process control and specification issues contributed to a rise in reported vaccine manufacturing deviations last year, a US FDA report finds.
Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.
Biocon's second fill/finish line at Bangalore site to come online later this year
Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.
Drugmakers have been invited to submit preliminary clinical evidence for cell and gene therapies under the new US FDA Regenerative Advanced Therapy designation
A clear interchangeability pathway is essential for the US biosimilar market say developers as they begin reviewing the much-welcomed draft FDA guidance.
High US approval rates of monoclonal antibodies is driving demand for Protein A, and with the arrival of biosimilars this is unlikely to slow down, says Repligen.
Update: Sandoz remains committed to launching 5 biosims by 2020
Expect industry guidance on product communication soon says US FDA Commissioner Robert Califf, though a more pragmatic approach to social media will be taken.
Regulations, recruitment and facility refits are holding continuous manufacturing back, but a Rutgers’ associate behind J&J’s recent success believes industry can overcome these hurdles.
Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.
