Regulations

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

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…

Vaccines the ‘backwaters of the pharma industry’ due to low price expectation

Historic low prices and the fact they are administered to healthy people means vaccine development plays second fiddle to biologics, according to a panel of experts. At the BPI West event in Santa Clara, California earlier this year, Rahul Singhyi, COO of Takeda vaccines, told delegates that vaccines used to be viewed as “the backwaters of the pharma industry.” Fast forward several months to the BPI Europe event in Vienna, Austria, and Bioprocess Insider asked four more experts within the…

Stem cell clinic crackdown continues with FDA letter to R3

Despite receiving an untitled letter from the US FDA over its promotion of unapproved stem cell therapies, Arizona firm R3 Stem Cell, LLC continues to push its questionable therapies to “vulnerable patients.” The US Food and Drug Administration (FDA) has put Scottsdale, Arizona-based company R3 Stem Cell on notice for marketing unapproved stem cell treatments. In the untitled letter dated May 30, the Agency said R3, through its affiliated clinics, offers unapproved stem cell products for serious conditions including Lyme…

On the origin of serum: Controlling FBS supply, a riposte from the ESPA

Do not confuse the methods and purposes for controlling the serum supply chain by misleading end-users into believing that some origins of serum are better and safer than others, says the European Serum Products Association (ESPA). Last month, Bioprocess Insider published an article entitled: ‘Quality FBS, or just BS? Industry turning to supply chain certification’. The article detailed a presentation from the International Serum Industry Association (ISIA) at BPI Europe in Vienna, Austria and highlighted the application of independent audits,…

Novartis wins approval for $2.1m gene therapy Zolgensma

Novartis says it is ready to launch Zolgensma (onasemnogene abeparvovec) within the next few weeks after receiving FDA approval for its spinal muscular atrophy (SMA) single-dose gene therapy. Zolgensma, a single-dose, one-time gene therapy has been approved to treat children less than two years of age with spinal muscular atrophy (SMA). “Today’s approval marks another milestone in the transformational power of gene and cell therapies to treat a wide range of diseases,” acting US Food and Drug Administration (FDA) commissioner…

FDA issues draft guidance on biosimilar analytical studies

The draft guidance advises industry to minimize differences between a biosimilar and its reference biologic including in the choice of expression system and manufacturing process. The US Food and Drug Administration (FDA) has been active in encouraging biosimilar development of late, publishing its long-awaited interchangeability guidance earlier this month. In its latest push the Agency has issued draft guidance entitled: ‘Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry.’ The document makes recommendations on…

Pfizer urges FDA for flexibility in considering interchangeability studies

The US FDA has published long-awaited final guidance on the interchangeability of biologics, calling biosimilar developers to carry out switching studies. At the last count, there were 19 biosimilar products approved by the US Food and Drug Administration (FDA) US though only a handful have been launched. None of these products have been deemed interchangeable, meaning they cannot be substituted for the reference biologic at the pharmacy level without the involvement of a physician. However, this theoretically could change going…

Subcutaneous success a boon for Halozyme, but biosimilars hit royalties

Roche’s subcutaneous Herceptin (trastuzumab) recently became the third product to be approved using Halozyme Therapeutics’s ENHANZE drug delivery tech. However, Halozyme’s royalties have been hit by biosimilar competition. Halozyme Therapeutics reported what it described as a “strong start to 2019” with revenues of $57 million (€51 million) – up 84% year-on-year – attributed to $30 million upfront license fee from a license agreement struck with argenx in February. That deal gives argenx access to Halozyme’s ENHANZE drug delivery technology to…

FDA pledges to support cell and gene therapy manufacturing innovation

Manufacturers aiming to follow Yescarta and Kymriah to market can count on FDA support after the agency said it will help cell and gene therapy firms adopt better production methods. A US Food and Drug Administration (FDA) spokesman told Bioprocess Insider the agency’s emerging technology team has been tasked with working with cell and gene therapy firms to “identify innovative approaches for efficient product manufacturing.” The move is part of a wider FDA effort to support modernization of drug manufacturing…

Success for Bioepis as FDA approves a second Enbrel biosimilar

The US Food and Drug Administration (FDA) has approved a second biosimilar of Amgen’s Enbrel (etanercept), Samsung Bioepis’s Eticovo. Korea’s Samsung Bioepis has seen regulatory approval for its etanercept biosimilar in numerous markets, including Korea, Europe, Australia, Canada, Brazil, Switzerland and Israel. Now the firm has had the molecule approved in the US under the brand name Eticovo. This is the second biosimilar of Amgen’s autoimmune disease drug Enbrel to be approved by the FDA. In August 2016, Sandoz received…