The EMA will assess a version of Roche’s breast cancer drug Herceptin (trastuzumab), the fifth biosimilar candidate submitted for review by Samsung Bioepis.
Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
J&J cannot stop Inflectra arriving in the US in October but warns Pfizer of the risk of launching it while the patent surrounding Remicade’s manufacture remains unresolved.
Ambition, hard work and a focus on quality has made Celltrion the ‘pioneers of the mAb biosimilar industry,’ the firm told Biopharma-Reporter during a tour of its biomanufacturing site in Songdo, Korea.
An invalidated Remicade patent has paved the way for Pfizer to launch Inflectra in October, but legal battles with J&J are far from over says an IP lawyer.
Asterias Biotherapeutics has selected Cognate BioServices for the process development and manufacture of its autologous dendritic cell vaccine candidate, AST-VAC1.
Lucentis biosimilar developer Formycon saw its share price jump 16% days after Pfizer abandoned efforts to create a rival version of Roche's blockbuster eye drug.
Highlighting indications approved through extrapolation and manufacturing information in drug labels are attempts to raise doubts over the safety of biosimilars, according to Sandoz.
Alexion has strengthened its Soliris (eculizumab) manufacturing IP and is developing a longer-acting C5 antibody ahead of potential biosimilar competition.
The EMA has said it will assess Samsung Bioepis’ version of Humira (adalimumab), which is the third biosimilar the (currently) London-based agency has accepted for review.
Pfizer has struck a strategic partnership with GE Healthcare to construct and equip a biomanufacturing centre focused on producing biosimilars for China.
The UK biosimilars industry has urged the Government to push for a single marketing authorisation in its upcoming negotiations with the EU, following today’s shock Brexit result.
The non-proprietary naming debate is “almost a little comical” says Sandoz, which argues a proposed four-letter suffix adds little to aid post-marketing surveillance of biological products.
Novartis will continue investing in its manufacturing network to support a biologics pipeline which includes five new biosimilars it expects to launch by 2020.
As part of a cost-savings restructure, Epirus is selling the assets from its $14m acquisition of Bioceros last September to its biosimilars partner Polpharma.
The US FDA has updated its draft nonproprietary naming guidance allowing drugmakers to submit up to 10 suffixes for each new biologic and biosimilar product.
Roche’s subcutaneous formulation of MabThera is about reducing the treatment burden for patients and not protecting it from impending biosimilar competition, the firm says.
Shire will retain Baxalta’s biologics expertise and continue assessing its manufacturing network following the completion of its $32bn acquisition, expected next month.
Pfizer remains confident it will launch its biosimilar Inflectra in the US this year despite J&J assuring stakeholders it will defend Remicade’s IP beyond 2018.
Fully understanding a molecule’s mode-of-action (MOA) will be essential as industry begins developing the third generation of biosimilar products, according to Formycon.
Biosimilar labeling will have to include a statement describing the product’s relationship to its reference drug, according to US FDA draft guidance published yesterday.
Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.
Celltrion’s supply chain and warehousing procedures ensure the safe storage of Remicade biosimilars as demand fluctuates across markets, the drugmaker says.
Is the debate surrounding unique international nonproprietary names (INNs) for biosimilar products a delaying tactic driven by reference biologic makers? One market analyst believes so.
It is still too early to tell how big an impact biosimilars will have in the US, according to an IP lawyer, a year after the FDA approved Sandoz’s Zarxio.
Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.
Approving a biosimilar for the same diseases as the originator drug based on extrapolated data rather than study results should remain a cornerstone of the review process say regulators and developers.
As competition begins to erode worldwide sales and litigation challenges Humira’s dominance, AbbVie says it will “prevail” with its new biosimilar strategy.
Sandoz says gradual uptake of its biosimilar will eat away at Amgen’s filgastrim market share which stands at 76% four months after Zarxio’s entry in the US.
