Date: 2017-11-01
Type of information: Development agreement
Compound: biopharmaceutical manufacturing and biologics process development.,biosimilar candidates (SB4 Enbrel (etanercept), SB2 Remicade (infliximab), SB5 Humira (adalimumab), SB3 Herceptin (trastuzumab), MK-1293 Lantus (insulin glargine)
Company: Merck&Co (USA - NJ) Samsung Biologics (South Korea)
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Rheumatic diseases - Dermatological diseases - Digestive diseases
Type agreement: development, commercialisation
Action mechanism:
Disease:
Details:
- • On February 20, 2013, Samsung Bioepis and Merck&Co announced they have entered into an agreement to develop and commercialize multiple pre- specified and undisclosed biosimilar candidates. Under the agreement, Samsung Bioepis will be responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. MSD will be responsible for commercialization.
Financial terms:
- Samsung Bioepis will receive an upfront payment from MSD, product supply income and will be eligible for additional payments associated with pre-specified clinical and regulatory milestones. Further financial terms were not disclosed.
Latest news:
- • On November 1, 2017, MilliporeSigma announced the signing of a Memorandum of Understanding (MoU) with Samsung BioLogics for a strategic alliance on biopharmaceutical manufacturing and biologics process development. The alliance would accelerate process development and clinical material production at small biotech start-ups focusing on novel drug development for which Samsung BioLogics acts as a contract manufacturer.
- Under the agreement, MilliporeSigma would provide process development and support technical training, in addition to its Mobius® single-use systems to Samsung BioLogics.
The new MoU is an extension of a MoU signed in 2014 that encompasses a long-term supply agreement where MilliporeSigma would provide raw materials for biopharmaceutical manufacturing. MilliporeSigma has been the key solution provider for Samsung BioLogics’ 30KL facility and 152KL facility in Korea, and has trained Samsung BioLogics team on building a robust biologics development process.
- • In February 2014, Merck&Co and Samsung Bioepis expanded the collaboration to include MK-1293, an insulin glargine biosimilar candidate currently in Phase 3 clinical development for the treatment of patients with type 1 and type 2 diabetes. Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration, except for MK-1293, which Merck&Co will continue to develop and manufacture. Merck&Co will be responsible in its partnered territories for commercialization of all approved products resulting from the collaboration.
- The portfolio includes biosimilar candidates in immunology, oncology and diabetes. There are five candidates in Phase 3 development : SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan], SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey], SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey], SB3 Herceptin (trastuzumab) [worldwide], MK-1293 Lantus (insulin glargine) [worldwide]. Each of these five biosimilar candidates is expected to be filed with regulatory authorities around the world between 2015 and 2016.
Is general: Yes
