FDA’s Janet Woodcook has defended delays in producing biosimilar interchangeability and labelling guidances, saying the scientific framework must first be ‘bulletproof.’
A copycat version of Amgen’s Enbrel has been approved in Korea, marking the first regulatory success for Merck & Co and Samsung Bioepis' biosimilar joint venture.
The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.
A leaked draft of Trans-Pacific Partnership negotiations reveals US plans to massively broaden IP for biologics and opens the door to monopolies, says MSF.
The European Commission has approved Pfizer’s acquisition of Hospira, providing the larger company first divests of its infliximab candidate and several sterile injectables.
Attaching PEG-chains to biological molecules can increase bioavailability and speed up development of protein-based therapies and biosimilars, says EMD Millipore which has inked a deal with PEGylation firm celares.
Remicade biosimilars have had no meaningful impact on AbbVie’s parallel TNF inhibitor Humira, management says, despite international Q2 sales of the mAb being down 14% year-on-year.
With Pfizer closing in on Hospira and Sandoz set to launch Zarxio in the US, it’s been a defining week for biosimilars, our BioFinance Vision feature explains.
Novartis’ Sandoz unit will begin selling a biosimilar for Amgen’s cancer treatment Neupogen on September 2, thanks to an appeals court ruling released Tuesday.
Sales of Jonson & Johnson’s Remicade have been hit by biosimilar competition but the firm remains confident it will maintain leadership in the immunology space.
A Medicare reimbursement policy proposing that biosimilars have the same pricing code as their reference products could ultimately reduce R&D investment, according to an industry group.
The fight over how to name biosimilars has taken a turn toward further clarification, with the WHO (World Health Organization) offering another, updated draft of its intended policy on "biological qualifiers" (BQ).
Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.
Celltrion’s Remsima campaign rolled into the US this week with another presentation of data showing that the Remicade (Infliximab) biosimilar is equivalent to the reference drug.
A biosimilar of Roche’s Lucentis could offer a safer universal treatment for wet AMD than off-label use of Avastin - as recommended by the WHO - according to Pfenex.
Under the bill first proposed in 2014, which won unanimous approval last week from a New Jersey Assembly committee, pharmacists would have to notify prescribers within five days of dispensing an interchangeable biosimilar.
US rheumatoid arthritis (RA) sufferers will still face high drug prices after biosimilar are available unless insurers reclassify such meds according to the author of research on biologic DMARD costs.
The EBG (European Biosimilars Group), a part of the EGA (European Generic Medicines Association), says that more complex systems for naming biosimilars increases the likelihood that physicians and pharmacists will leave something out and disrupt the tracking...
The Medicines Evaluation Board (MEB) of the Netherlands has updated its position about biosimilars, saying the relatively new products “have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality,...
Data must drive US FDA efforts to determine biosimilar interchangeability according to a Pfizer exec who told Goldman Sachs conference delegates not to expect a definition anytime soon.
With the release of four different documents around the pricing and use of biosimilars this week, the US CMS (Centers for Medicare and Medicaid Services) is making clear it will fully encourage states to call on prescribers to use cost-effective biosimilars...
A Georgia bill, which passed both the state House and Senate last week, calls for new language on biosimilar labels that say that the product is “interchangeable.”
Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.
A district court judge from California has denied an injunction by Amgen meant to stop the launch of the first biosimilar approved by the US FDA – Sandoz’s Zarxio (filgrastim-sndz).
More than a year since California saw its previous biosimilar substitution bill vetoed by its governor and more than two years since Illinois tried its hand, both are again looking to become the ninth and tenth states to see new substitution laws.
The US FDA has delayed an advisory committee review of Celltrion's Remicade (infliximab) biosimilar after asking the South Korean drugmaker for more information.
Apotex’s Neupogen (filgrastim) copycat Grastofil could be on US pharmacy shelves as early as December, after the US Food and Drug Administration (FDA) started its review this week.
Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade.
The US FDA has set a date to review its first monoclonal antibody (mAb) biosimilar: a version of J&J’s Remicade marketed by Pfizer takeover target Hospira.
Big biotech firms risk the empty pipeline pitfalls of old pharma if they protect their drugs from biosimilars rather than invest in innovation, ex-Teva CEO Jeremy Levin warns.
