Global Markets

Biocon biosimilar captures 21% of US Neulasta market, eyes capacity boost

Biocon says it is making a “very significant expansion” in its manufacturing capacity to feed the demand for biosimilars, including its pegfilgrastim product Fulphila. In June 2018, Fulphila became the first biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim) to win US Food and Drug Administration (FDA) approval. The biosimilar is marketed in the region by Mylan but manufactured by partner Biocon. In its Q1 FY2020 results, the Indian drugmaker claimed Fulphila captured a 21% volume share of the US pegfilgrastim…

A booster shot for vaccines: Univercells working to cut production costs

Vaccines cost too much to make according to Univercells, which aims to have a novel platform ready for commercial-scale production by 2020. Vaccines have had a dramatic impact on human health. One recent study argued that vaccine development “represents humankind’s most important and successful endeavor… over the last 200 years” [1]. Many diseases that caused millions of deaths in generations past have been stopped in their tracks by industry-supported vaccination programmes run by entities like World Health Organization (WHO), UNICEF and…

Challenging the vaccine space: The problem with pioneers

With GSK, Merck, Pfizer, and Sanofi dominating the vaccine space, “the only thing pioneers get are arrows in their back,” say a group of industry experts. At BioProcess International Europe in Vienna, Austria in April, Bioprocess Insider hosted a vaccine-focused roundtable. The panel brought together some of the world’s leading luminaries within the space to discuss some of the major challenges within the vaccine industry, from technology challenges to the online army of anti-vaxxers. The group also spoke about the…

On the biotech doorstep: Why Sartorius moved its bioanalytics to Cambridge

Sartorius Stedim Biotech says it consolidated its cell line and testing solutions in Cambridge, Massachusetts to be close to the industry it serves. Services like analytics, QC and characterization, have traditionally been done inhouse. “It was done by what were referred to at one time as testing houses. These were mostly very large QC labs that focused on QC release for firstly traditional pharma products, but that migrated to the biologics,” Maurice Phelan, site head of Cambridge US, Sartorius Stedim…

Big Pharma M&A a boon for business, says Thermo Fisher

Thermo Fisher says it is well positioned to benefit from recent M&A activity within the biopharma space: Takeda and Shire, BMS and Celgene, AbbVie and Amgen. So far, 2019 has been a big year for Big Pharma megamergers. Takeda completed its $62 billion (€56 billion) takeover of Shire in January, Bristol-Myers Squibb is moving closer to joining with Celgene in a $74 billion deal, and last month AbbVie entered an agreement to buy Allergan for $63 billion. The biopharma space…

Germany’s Merck fully prepped for a ‘worst-case scenario’ Brexit

Merck Life Science says it has undergone Brexit preparations to limit supply chain issues if the UK leaves the European Union without a deal in place. In 2016, a referendum in the UK resulted in a slight majority of an ill-informed electorate to vote to leave the European Union (EU). Three years on and with no agreement in place as it stands, the UK is set to leave the bloc and the single-market economy on October 31 without any arrangements…

Shingrix a ‘standout’ in GSK’s vaccine strong Q2

GlaxoSmithKline (GSK) has described its shingles vaccine Shingrix as a driving force in its Q2 sales results. The firm is expanding capacity to keep up with demand. For the second quarter 2019, group sales stood at £7.8 billion ($9.8 billion), up 7% year-on-year. GSK saw a 1% decline to £4.3 billion in its pharmaceuticals division but was boosted by strong performances in vaccines and consumer. Management attributed vaccine sales of £1.6 billion – up 23% on the same period last…

Alexion on track with FcRn antibody after manufacturing hitch

After inheriting an impurity in the drug product of early-phase antibody ALXN1830, Alexion Pharmaceuticals says new batches will be available by the end of the year. In November 2018, Alexion Pharmaceuticals acquired Syntimmune in a deal worth up to $1.2 billion, adding ALXN1830, a clinical-stage humanized monoclonal antibody that inhibits the interaction of neonatal Fc receptor (FcRn) in trials for warm autoimmune hemolytic anemia (WAIHA) and generalized myasthenia gravis (gMG). But earlier this year, the firm discovered an issue in…

Politics, patents and pricing: the future of the US biosimilars market

In the US the ongoing political debate about patents and prices will determine the long-term viability of the US biosimilars market, says an industry expert. The US biosimilar drug market was established in 2015 with the approval of Zarxio, Sandoz’s version of the Amgen drug Neupogen (filgrastim). Zarxio quickly established itself – the drug accounted for 45% of all the short-acting filgrastim used in the US last year. In contrast, the wider market has been slow to develop. Legal complexity…

‘Bioprocessing ecosystem is on fire,’ says analyst

Sales grew 21% year-on-year at Sartorius’ H1 2019, while Repligen reported preliminary Q2 growth of nearly 50%. The bioprocessing sector ‘is on fire,’ says Jefferies’ analyst Brandon Couillard. Repligen Corporation published its preliminary Q2 results in an SEC filing last week, saying it expects sales of $70-71 million, compared to $47.7 million for the three months ended June 30, 2018. This would represent a 48% increase year-on-year. “The 8-K did not offer much color on specific drivers, but momentum across…