Just days after the release of its Biosimilar Action Plan to encourage generic competition, the US FDA has approved another biosimilar product: Pfizer’s answer to Amgen’s Neupogen, ‘Nivestym’.
Major pharmaceutical firms Novartis, Roche, and Pfizer have reacted to the US FDA’s Biosimilar Action Plan, which aims to “strike a balance” between innovation and market competition.
AbbVie’s mega-blockbuster Humira is facing biosimilar competition, but another patent licensing agreement, this time with Mylan, sees the company securing exclusivity through to 2023 in the US.
South Korea’s SFC has alleged that Samsung BioLogics had intentionally omitted information regarding the joint venture agreement with Biogen that created Samsung Bioepis.
The US FDA has issued a complete response letter to Amgen for its biosimilar version of Roche’s Herceptin, marking the agency’s third trastuzumab candidate rejection this year.
The FDA has approved Pfizer’s Retacrit, a biosimilar alternative to Amgen’s Epogen and J&J’s Procrit, which the company will price at a "significant discount."
The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.
Mundipharma says it is not concerned at arriving second to market with a trastuzumab biosimilar after inking a deal to commercialise Celltrion’s Herzuma in seven European countries.
Charles River says increased demand for biologics services prompted its recent Devon Park facility acquisition, bringing its Pennsylvania site count to three
A warning letter at manufacturing partner Celltrion could delay approvals of the potential migraine prevention monoclonal antibody fremanezumab and two biosimilar candidates, says Teva.
Patient advocacy groups have called on Congress to address patient safety concerns in oversight hearings, following an influx of US FDA biosimilar drug approvals.
Amgen has announced plans for a US biomanufacturing facility, similar to its flexible and single-use Singapore plant, as part of $3.5bn freed through tax reforms.
Cellular Biomedicine Group Inc (CBMG) has selected GE Healthcare’s FlexFactory technology for its CAR-T therapy production facility in Shanghai, China.
Celltrion has shelved plans for a third biomanufacturing plant at its site in Incheon in favour of an overseas site it says will help ensure biosimilar supply.
Did you miss any of the biosimilar approvals, launches or guidance this year? Well Biopharma-Reporter brings you a special timeline of events to help guide you into the new year.
Pfizer says it remains committed to Inflectra and partner Celltrion after gaining US FDA approval for another infliximab biosimilar, Ixifi, developed in-house.
The US FDA has approved Admelog as a follow-on drug five months after it received European market authorisation as a biosimilar of Eli Lilly’s Humalog (insulin lispro).
The EMA has accepted to review Mylan’s trastuzumab and pegfilgrastim biosimilars amid remediation efforts at biomanufacturing partner Biocon’s fill and finish plant in India.
Physicians and patients still lack information about biosimilars says an industry consultant, despite efforts from advocacy groups and national healthcare systems.
