Construction of Samsung Biologics’ Plant 4 is on schedule with operations set to start in October, the company confirmed in its Q2 results this morning.
Biogen will ‘substantially eliminate’ commercial infrastructure for Alzheimer’s drug Aduhelm and take additional cost-reduction measures, the company announced as it released its Q1 2022 results this morning.
Korean contract development and manufacturing organization, Samsung Biologics, announced strong financial results today for Q1 of its fiscal year 2022.
Biogen Inc and Xbrane Biopharma AB have entered into a commercialization and licensing agreement on Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA.
US FDA gives approval to Samsung Bioepis’ Humira biosimilar and Pfizer’s Rituxan biosimilar, as the number of such medicines gaining entry onto the US market steadily increases.
An executive at Samsung is issued an arrest warrant, as prosecutors in South Korea continue to look into the accounting case leading up the IPO of Samsung BioLogics.
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’.
Samsung plans to invest KRW 180 trillion into its various businesses over the next three years, including in biomanufacturing-focused Samsung BioLogics.
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.
Samsung Bioepis has received European Commission approval for Ontruzant, its version of Roche’s best-selling breast cancer mAb Herceptin (trastuzumab).
Janssen has withdrawn a lawsuit against Samsung Bioepis alleging infliximab manufacturing patent infringements after receiving process information from the Korean drugmaker.
The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.
The EMA has said it will assess Samsung Bioepis’ version of Humira (adalimumab), which is the third biosimilar the (currently) London-based agency has accepted for review.
Benepali has become the first biosimilar of Amgen’s Enbrel (etanercept) approved in Europe and marks the first regulatory success for Samsung Bioepis – a joint venture between Samsung Biologics and Biogen.
Samsung Bioepis will base its European operations in the UK at an entity set up to hold marketing authorizations for biosimilars it has filed for EMA review.
A copycat version of Amgen’s Enbrel has been approved in Korea, marking the first regulatory success for Merck & Co and Samsung Bioepis' biosimilar joint venture.
Biogen Idec will make Samsung Bioepis’ Enbrel (etanercept) biosimilar at the Danish plant that supplies its originator products, Tysabri (natalizumab) and Avonex (interferon beta-1a).
