Pfizer has launched the first biosimilar to J&J’s Procrit and Amgen’s Epogen in the US at a ‘significant discount’ to competitors’ wholesale acquisition costs.
Unlike the European system, manufacturing authorisation holders in Jordan must own or operate from a manufacturing facility to apply for biosimilar approval, says JFDA executive.
As an increasing number of biosimilar developers target the European market, lesser-known firms may explore alternative commercialisation strategies, says Iqvia executive.
After the business was asked by the US FDA to provide more data to secure an approval for its biosimilar, Sandoz decided not to pursue its regulatory filing any further.
Within days of Samsung Bioepis sending its Soliris candidate to the clinic, the firm details its development process, novel biologics ambitions, and plans to become ‘the single dominant player in biosimilars’.
The first MabThera biosimilar is expected to enter the US market in the first half of 2019, followed by Herceptin and Avastin versions in the second half of the year, says CEO.
Leaf Expression Systems’ technology enables the manufacture of proteins, vaccines and complex biomolecules without using animal-based products, says recently appointed chief executive.
BioPharma-Reporter (BPR) discusses with Jennifer Fox (JF), co-chair of Brinks Gilson & Lione’s biopharma practice group, the provisional detail revealed from the US administration’s proposed trade deal with Mexico, and its potential impact on the...
Samsung plans to invest KRW 180 trillion into its various businesses over the next three years, including in biomanufacturing-focused Samsung BioLogics.
A US district court has denied Johnson & Johnson’s motion to dismiss Pfizer’s Inflectra lawsuit, a case claiming anticompetitive practices blocked US uptake of the Remicade biosimilar.
A Phase I clinical trial to examine the safety and pharmacokinetics of BAT1806, an Actemra biosimilar, is to be conducted by Chinese pharmaceutical company Bio-Thera.
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.
