Global Markets

Biocon investing $200m into second MAb plant in India

Construction is under way on a hybrid biomanufacturing plant at a site in Bangalore, set to support Biocon’s growing monoclonal antibody (MAb) portfolio. Indian drugmaker Biocon has a growing pipeline of biological products, including Ogivri, the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved by the US Food and Drug Administration (FDA) last December, and Fulphila, the first US biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), approved in June. Both are marketed by Mylan, but including products developed in…

Samsung Bioepis riding the biosimilar third wave

Samsung Bioepis has beefed up its biosimilar pipeline with versions of Lucentis (ranbizumab) and Soliris (eculizumab) under development. In Europe, South Korean biopharma firm has achieved commercial success with four biosimilar products. In the US – through commercialization partner Merck & Co. – it has launched one and has two other biosimilars under review. When looking at the market and large pharma biosimilar makers such as Pfizer and Sandoz “we are up to par with the ‘big boys’ in terms…

Avid to triple process dev capacity on early-stage demand

Since becoming a pure-play CDMO, Avid Bioservices says it is experiencing growing demand for process development services and has begun expanding capabilities at its site in California. At the turn of the year, Avid Bioservices became a pure contract development and manufacturing organization (CDMO) by selling off its internal monoclonal antibody programs to Oncologie and dropping its Peregrine Pharmaceuticals nametag. To grow the business further, Avid has begun a project to expand its process development services by adding 6,000 square feet…

Turning of the tide: High potential for oligos, says survey

Within the tides space, oligonucleotides hold the most opportunity for commercial success and growth say respondents of a KNect365 survey. The oligonucleotide therapeutic market could be viewed as having suffered a false start. The potential of antisense oligonucleotides to silence specific genes was jumped upon in the 1980s with numerous companies investing heavily in the field and commencing hundreds of clinical trials. However, the unexpected complexity of oligonucleotide pharmacology somewhat dampened the sector. And though the US Food and Drug…

Merck & Co. pumping up to $16bn into biomanufacturing

Merck & Co. has upped its capital expenditure plans through 2022 to increase manufacturing capacity in areas including oncology and vaccines. At the beginning of the year, tax changes in the US led to a wealth of potential investment promises by Big Pharma looking to benefit from lower corporate rates and to repatriate cash from overseas. Merck & Co. (known as MSD outside North America) was one such firm, and in its February earnings call it announced plans to invest…

Janssen closing in on ‘holy grail’ through $82m HIV vaccine plant

Janssen has opened a single-use manufacturing facility in Leiden, the Netherlands to support the commercialization of its preventative HIV vaccine candidate. Commissioned in 2014, the multipurpose vaccine production facility is being inaugurated today (Thursday October 25) in Leiden, the Netherlands and will initially be used to manufacture the firm’s investigational mosaic HIV-1 preventive vaccine. The facility represents an investment of €72 million ($82 million). The facility came about following the 2014 Ebola outbreak in West Africa, Dirk Redlich, VP of…

Novartis growing CAR-T network amid slow Kymriah sales

Novartis says it remains confident Kymriah will pull in $200 million in 2019 through the remediation and ramp-up of its CAR-T manufacturing network. For the third quarter 2018, Kymriah (tisagenlecleucel) netted Novartis $20 million (€17.4 million), making a total of $48 million for the first nine months of the year. The product became the first chimeric antigen receptor (CAR) T-cell to be approved in August 2017. Elizabeth Barrett, chief executive officer of oncology at Novartis, said the sales figures were…

Merck building second biologics plant at Irish site, adding 170 jobs

The construction of a vaccine and biologics production at a site in County Carlow is the latest commitment to Ireland, says Merck & Co. Merck & Co. – known as MSD outside of North America – will construct a second plant at its site in Carlow, Ireland, about 80km south-west of Dublin. The project will create 170 new jobs. “The facility will focus on the production of vaccines and biologics and there will also be an expansion of warehouse and…

Merck drops Lantus biosimilar, blames pricing and production cost concerns

Merck & Co. has ended the commercialization of Lusduna, a version of Sanofi’s Lantus (insulin glargine), and will pay Samsung Bioepis a termination fee of around $155 million. In 2014, Merck & Co. (known as MSD outside of North America) entered into an agreement with Korean biosimilar maker Samsung Bioepis to commercialize an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes. The product, Lusduna, formerly MK-1293, was approved in Europe in January 2017…

Genmab on CMO use: ‘Keep brains inhouse, hands outside’

Genmab says it chooses to outsource all its biomanufacturing having previously had its fingers burnt buying a facility in Minnesota, now owned by Takeda. In early 2013, Danish drugmaker Genmab A/S sold its non-plasma-derived antibody manufacturing facility in Brooklyn Park, Minnesota, to Baxter Healthcare Corporation for $10 million (€8.7 million). The 215,000 square-foot plant housed 22,000 L of mammalian cell culture bioreactor capacity, and was originally acquired by Genmab from PDL BioPharma in 2008 at a cost of $240 million.…