Global Markets

We are in the ‘golden age for the CDMO space,’ says Thermo Fisher

With over 75% of new molecules coming from small and emerging biotech, opportunities for third-party manufacturers have never been so large says Thermo Fisher CEO Marc Casper. Thermo Fisher jumped into the third-party biomanufacturing space in August 2017 through its acquisition of contract development and manufacturing organization (CDMO) Patheon for around $7.2 billion (€6.4 billion). The firm has also had capabilities in the CDMO since the early 2000s through its clinical trials’ service offerings. Speaking at the 2019 Barclays Global Healthcare Conference,…

Pfizer’s trastuzumab becomes US biosimilar number 18

The US Food and Drug Administration (FDA) has approved Trazimera, Pfizer’s version of Roche cancer drug Herceptin (trastuzumab). Trazimera has been approved as a biosimilar version of Herceptin to treat human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is the fourth version of the Roche bestselling monoclonal antibody (MAb) to receive the regulatory thumbs up in the US. Mylan’s Ogiviri received approval in December 2017 and in the past…

Celltrion injects $51m to get under the skin of infliximab competitors

Celltrion Pharm has pledged KRW 58.2 billion won ($51 million) to establish a production site for Remsima SC, a subcutaneous version of its Remicade biosimilar. Korean drugmaker Celltrion has achieved regulatory success for its biosimilar of J&J’s Remicade (infliximab) across several key markets and is now looking to receive approval and launch a subcutaneous version of the immunosuppressive monoclonal antibody. To prepare for launch, the firm has committed KRW 58.2 billion won ($51 million) to its site in Cheongju, South…

Fresenius awaiting success before investing further in biosimilars

Having acquired a portfolio of biosimilar candidates in 2017, Fresenius Kabi says it needs “to earn the right to spend” further in the space through commercial sales. Fresenius Kabi entered the biosimilar space in 2017 through the €656 million ($645 million) acquisition of Merck KGaA’s pipeline and Swiss-based R&D staff. The total number of molecules in development have not been divulged, but Fresenius has said it is in the high single-digits and includes versions of AbbVie’s Humira (adalimumab), Amgen’s Neulasta…

From Sartorius to VC, Dynamk’s new MD talks life science investment

AI, regenerative medicine enabling technologies, and clinical diagnostics are major investment opportunities, says life science executive Reinhard Vogt who has joined Dynamk Capital. Reinhard Vogt served as an executive at Sartorius AG for over 35 years. During his tenure, he was responsible for the strategic development of the firm’s Bioprocess Division that grew from around $30 Million to around $1.2 billion today, reached through a combination of strong organic growth and a strong focus on M&A and the integration of…

Charles River CRO to continue to expand biomanufacturing support biz

Following a strong year for its manufacturing services division, Charles River Laboratories intends to invest further to benefit from the high growth in biologics. Contract Research Organization (CRO) Charles River reported full year 2018 revenues of $430 million (€381 million) within its manufacturing support division, up 11.9% on the previous year. The unit provides manufacturing services for drug developers, including cell line characterization, lot release testing and stability studies. Increasingly, the business has focused on biologics, reflecting industry’s shifting pipelines,…

Samsung Bioepis inks biosimilar deals to enter China

Samsung Bioepis has teamed with C-Bridge Capital to bring its third-wave biosimilars to the Chinese market. C-Bridge will establish a new company, AffaMed Therapeutics, under terms of the deal, and will license multiple biosimilar candidates from Samsung Bioepis to commercialize in China. These include the third-wave biosimilar candidates SB11 and SB12 – versions of Roche/Novartis’ Lucentis (ranibizumab) and Alexion’s Soliris (eculizumab) – and SB3, a biosimilar of Roche’s Herceptin (trastuzumab). The deal comes weeks after a partnership deal with 3SBio…

VBAs and marketing campaign to aid RNAi Onpattro ramp up, says Alnylam

Around 200 patients have so far been treated with Onpattro (patisiran), the first approved RNA interference (RNAi) drug, bringing in $12.5 million for Alnylam. In August 2018, the US Food and Drug Administration (FDA) and the European Commission (EC) approved Alnylam Pharmaceuticals’ Onpattro for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The approvals heralded in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. Onpattro works by silencing a portion of RNA involved…

Roche looks to delivery device to keep Lucentis biosimilars at bay

Roche says its Port Delivery System will keep Lucentis (ranibizumab) competitive against upcoming biosimilar competition. Lucentis pulled in CHF 1.66 billion ($1.66 billion) in US sales for Roche in 2018, up 18% on the year before. The drug is marketed in Europe by fellow Swiss firm Novartis. The firm attributed the increase to the “ongoing rollout of prefilled syringes and sales increases in all approved indications.” The monoclonal antibody, approved for eye conditions including neovascular (‘wet’) age-related macular degeneration, macular…

Madison expansion will add commercial capacity, says Catalent

Plans to invest $200 million laid down last year will put Catalent in a position to offer commercial manufacturing from its Madison, Wisconsin facility, the CDMO says. In November 2018, contract development and manufacturing organization (CDMO) Catalent announced its intentions to invest across its two biomanufacturing sites. The board laid down plans to plough $100 million (€88 million) into its Madison, Wisconsin plant to add a fourth and fifth biomanufacturing train. During Catalent’s second quarter FY2019 financial call this week,…