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.
Provisional results from a survey evaluating the reputations of major biopharmaceutical countries indicate the US, Germany and Japan are regarded as ‘tier one’ nations, followed closely by Sweden and the UK.
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.
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.
