Global Markets Archives - Page 25 of 41 - BioProcess InternationalBioProcess International

Momenta drops Humira biosimilar, pays GSK $43m in manufacturing hit

Momenta says planned runs at manufacturing partner GSK could be reattributed to another product as it ends development of M923, a biosimilar candidate to Humira (adalimumab). In October 2018, Momenta Pharmaceuticals said it was exiting the biosimilars space following a lengthy strategic review process to concentrate on its novel biologics pipeline. The company told Scrip it would terminate all but two late-stage programs, a biosimilar version of AbbVie’ blockbuster Humira (adalimumab) and a biosimilar of Regeneron’s Eylea (aflibercept). Ten months…

Pro-biosimilar policies will not ignite US market, Amgen

by Dan Stanton

Amgen says the US needs a vibrant competitive biologics market but must avoid policies that tilt the playing field in favor of biosimilar makers. Biosimilars made an initial mark in the US when the Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim) in 2015. But in the proceeding four years, the sector has somewhat stalled – despite 22 more approvals – amid ongoing political debate, legal complexities and pricing/reimbursement. The idea of Congress addressing drug pricing and patent issues,…

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

by Dan Stanton

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

by Gareth Macdonald

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

by BPI Staff

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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…