Wednesday, May 24, 2023 Daily Archives

Second CRL leaves Alvotech with potential Humira biosimilar delay

US approval of Alvotech’s Humira (adalimumab) biosimilar could be delayed by six months after the FDA found further issues at a manufacturing facility in Reykjavik, Iceland. Thanks to a 2017 settlement with AbbVie, Amgen launched the first biosimilar of best-selling monoclonal antibody Humira earlier this year. At the end of next month, up to nine more biosimilars could be competing for a slice of the $18.6 billion market. Iceland-based firm Alvotech has two separate applications for AVT02, with the first Biologics…

Thermo Fisher opens drug product facility in Singapore

Thermo Fisher Scientific said the opening of its drug product facility in Singapore will advance research, development, and production of medicines and vaccines. In October 2020, the firm announced it would add two filling lines in Singapore to support growing demand for sterile injectables. The expansion was valued at $130 million at time of construction but Thermo Fisher said it could not disclose specific financials now the plant is open. The facility has been established with the support of the…

Moderna lays out $322m for mRNA manufacturing plant in MA

Moderna has bought an empty biomanufacturing facility in Marlborough and is planning a 60,000 square-foot expansion as it continues to invest in internal capabilities. The agreement sees messenger RNA (mRNA) titan Moderna add a second facility in Massachusetts, a new but empty plant located at 149 Hayes Memorial Drive, bought from the Oxford Properties Group. The 24-acre parcel of land includes a 140,000 square-foot facility to house manufacturing and office space. According to notes from a City of Marlborough public…

Inhouse vs external capacity? Choose both, says Bayer

Inhouse and outsourcing comes with risks, but according to Bayer a mixture of both capacities is needed.  Presenting at BPI Europe 2023 in Amsterdam, Ulrich Ruemonapp, head of launch preparation and coordination at Bayer discussed the pros and cons of outsourcing and provided delegates with information on how to navigate the selection of and relationship with your chosen contract manufacturing organization (CMO). He outlined how both options come with potential risk and reward. If you decide to stay inhouse –…