Global Markets

Jazz on Erwinaze shortage: ‘We can’t sell what we don’t have’

Jazz Pharmaceuticals says further supply outages for its cancer enzyme Erwinaze are expected amid ongoing manufacturing issues at its sole CMO. For the third quarter 2018, Jazz Pharmaceuticals reported net sales of its acute lymphoblastic leukemia (ALL) drug Erwinaze (asparaginase Erwinia chrysanthemi) of $41 million (€36 million), down 16% on the same period last year. “Supply challenges continued to impact product availability in the third quarter,” CEO Bruce Cozadd told stakeholders on a conference call (transcript here). He predicted further…

GE to use Wego to make single-use products in China, for China

Wego Pharmaceutical Co. will manufacture single-use bioprocessing consumables on behalf of GE Healthcare from its facility in Weihai, China. The partnership with China’s Wego, financial details of which have not been divulged, will decrease product delivery times of GE Healthcare’s single-use bioprocessing products for Chinese biopharmaceutical companies, the firm says. “This collaboration helps local Chinese biomanufacturers focus on bringing much needed therapeutics to Chinese patients,” Olivier Loeillot, general manager of BioProcess at GE Healthcare Life Sciences, told BioProcess Insider. “Local…

Bye bye biosimilars: Big Pharma’s imminent exit in sight, says expert

As prices drop, Big Pharma will exit the biosimilar space over the next five to 10 years, says industry expert Sarfaraz Niazi. Amgen, Novartis and Pfizer refute the claim, saying they are in the sector for the long-term. Blockbuster biologic originator companies are, by definition, Big Pharma firms and the target of biosimilar developers. Roche and AbbVie, two of the firms most susceptible to biosimilar erosion, have vocalized the need for a stringent regulatory framework – including calls for appropriate…

Novartis pulls US rituximab program citing FDA data demands

Novartis subsidiary Sandoz has decided not to pursue a biosimilar of Roche’s Rituxan in the US after receiving a complete response letter from the FDA. In June 2017, biosimilar developer Sandoz received approval in Europe for Rixathon, a version of Rituxan (rituximab), which Roche markets as Mabthera in the region. But across the Atlantic, the Swiss biopharma has failed to replicate such regulatory success, and received a US Food and Drug Administration (FDA) complete response letter (CRL) in June this…

Astellas invests $256m in Japanese and US antibody and cell therapy sites

Astellas says it is responding to the supply needs of future pipeline by constructing two multi-modality Japanese sites and relocating a regenerative medicine plant in Massachusetts. Both R&D and manufacturing are being looked at through the expansion of sites in Toyama and Tsukuba, Japan, and Massachusetts, US to progress the development and commercialization of Asellas’ portfolio. “Astellas is responding to the progress being made in the development and launch of new drugs from its existing portfolio and pipeline,” a spokesperson…

GSK to ramp-up Shingrix vaccine as demand outstrips supply

GSK says it is pleased with the launch of its shingles vaccine Shingrix but supply going forward is limited by a lack of manufacturing capacity. In October 2017, GlaxoSmithKline received approval from the US Food and Drug Administration (FDA) for Shingrix (Zoster Vaccine Recombinant, Adjuvanted), its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). A year on, the Big Pharma firm announced Shingrix sales of £286 million ($372 million) for its third quarter, helping to boost its…

Q3 saw $1.5bn in biotech IPOs, and no slowdown in sight

The biotech sector saw the largest capital investment over the past quarter and life sciences’ momentum has far from peaked, says accounting firm CohnReznick. In the past financial quarter, life sciences and biotech initial public offerings (IPOs) pulled in $1.5 billion (€1.3 billion) in capital investment. According to national professional services and accounting firm CohnReznick, the sector was the number one industry for IPOs, with 20 deals taking place in the quarter, representing 30-35% of all deals. “There has been…

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…