Global Markets Archives - Page 26 of 41 - BioProcess InternationalBioProcess International

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

by Dan Stanton

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…

Multiple myeloma MAb helps drive Q2 as J&J looks to subcu formulation

by Dan Stanton

J&J has reported a 57% year-on-year growth for its multiple myeloma monoclonal antibody Darzalex (daratumumab) and is now hoping to increase adoption through a subcutaneous formulation. For its second quarter 2019, Johnson & Johnson clocked in sales of $10.5 billion (€9.4 billion) in its pharmaceutical division, up 4.4% on the same period last year. The firm attributed this to several of its biological products, not least Darzalex (daratumumab) which grew 57% year-on-year to pull in $774 million in global sales.…

Biocon going digital to fix insulin plant hit with another FDA 483

by Dan Stanton

Adopting a digital-based Quality Management System will help Biocon remediate issues at its insulin glargine facility in Malaysia, the firm says. An inspection by the US Food and Drug Administration (FDA) between June 24 and July 5 has resulted in a Form 483 with 12 observations at Indian drugmaker Biocon’s facility in Malaysia. The drug product and drug substance site will produce a follow-on insulin glargine referencing Sanofi’s Lantus intended for the US market. “We believe these 12 observations across…

Teva partnership looks to up its biologics productivity

by Dan Stanton

Teva has teamed with Just Biotherapeutics to develop a high productivity biomanufacturing process as it focuses its efforts towards biopharmaceuticals. The partnership aims to develop methods to lower the cost of biomanufacturing. Just Biotherapeutics – recently acquired by Germany’s Evotec – will design and development a high yielding manufacturing process for one of Teva Pharmaceutical Industries’ complex products. Further details of the process, molecule or the finances of the deal were not answered by either company when contacted by this…

Spark on the evolving commercial cell & gene therapy space

by Dan Stanton

Single-use technologies and CDMO expansions have resolved some of the issues in the cell and gene therapy space but analytical and supply chain challenges still exist, says Spark Therapeutics. Spark Therapeutics is one of a handful of companies to achieve regulatory success with an advanced therapy, specifically its gene therapy for inherited vision loss Luxturna (voretigene neparvovec) which received US approval in December 2017. Speaking as part of a panel discussion at the BPI Theater at BIO in Philadelphia last…

Henlius’ trastuzumab: EU to assess first China-made biosimilar

by BPI Staff

The European Medicines Agency (EMA) has accepted to review a version of Roche’s cancer drug Herceptin (trastuzumab) developed by Chinese biotech Henlius. The European agency has officially accepted to review the Marketing Authorization Application (MAA) of Shanghai, Henlius’ trastuzumab molecule HLX02, making it he first biosimilar developed and made in China to be up for review. Scott Liu, co-founder and CEO at Henlius, said the review “shows that our clinical, medical, regulatory affairs and quality system capabilities have been internationally…

Biotech money: Global funding down despite spate of IPOs

by BPI Staff

A decline in venture capital (VC) funding has been offset by a flood of IPOs with growth coming from non-US biotechs, according to a Jefferies analyst. For April and May 2019, biotech funding has declined 6.5% year-on-year to $9.3 billion (€8.3 billion) according to Jefferies analyst David Windley. This, he said in a note, is due to a 46% drop in VC funding as the private market continues to be less kind to biotech over the past few periods. “Both…

Catalent to invest up to $10m into ex-BMS fill/finish site

by Dan Stanton

Catalent will retain all 700 staff and invest up to $10 million into a site in Italy it is acquiring from Bristol-Myers Squibb. The deal, announced this week, will see the contract development and manufacturing organization expand its biologics network outside of the US through the addition of a sterile product manufacturing and packaging facility in Anagni, Italy. Financial details regarding Catalent’s first biologics manufacturing facility in Europe have not been divulged, but a spokesperson told this publication the CDMO…

The scale-X factor: Univercells wins $14m grant to make low-cost measles vaccines

by Dan Stanton

Univercells aims to make affordable measles and rubella vaccines using its NevoLine biomanufacturing platform incorporating the scale-X fixed-bed bioreactor. In a consortium with Batavia Biosciences and Natrix Separations, Belgium-based Univercells has been able to develop a manufacturing platform that has slashed the cost of production of inactivated polio vaccine (sIPV). Now, through a $14.3 million (€12.8 million) from the Bill & Melinda Gates Foundation, the firm is looking to adapt the platform to produce low-cost measles and rubella (M&R) vaccines…