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.
Amgen has benefited from enhanced regulatory discussions surrounding biosimilars, the firm says, as it develops a pipeline of nine products alongside its own biologics.
Sandoz’s recommendation was an “inevitable step” in the introduction of biosimilars to the US, and the US FDA should expect more submissions according to a consultant.
Australia’s TGA (Therapeutic Goods Administration) is shifting its stance on the way it plans to name biosimilars to keep the country more in line with the WHO’s (World Health Organization) proposed policies.
President Obama in his State of the Union address has called for the power to personally make stronger trade agreements – bringing divisive EU deal TTIP closer to adoption and angering campaigners for drugs access.
So far most biosimilars filed in the US have been ‘low risk’ according to contractor BioOutsource, which warned that developers seeking approval for copycat mAbs face higher legal and regulatory hurdles than in Europe.
Copycat versions of biopharmaceuticals in the US are a step closer to reality after an FDA review committee recommended a biosimilar of Amgen’s Neupogen.
Manufacturing issues surrounding low protein content in batches of Sandoz’ Neupogen copycat have been resolved ahead of an FDA review which could herald the first US biosimilar.
Baxter has sold its pandemic flu portfolio and Vero cell technology to Nanotherapeutics in preparation for the launch of its haematology and oncology-based spinout company Baxalta.
In the ongoing fight over whether US pharmacists will be allowed to prescribe biosimilars in place of their reference products, the Generic Pharmaceutical Association has agreed on “compromise legislation” with innovator manufacturers.
The first rival to AbbVie’s mega-blockbuster arthritis treatment Humira has hit the shelves in India, with Zydus Cadila claiming its launch began on Tuesday.
Biopharma heavyweights Amgen, Pfizer and a number of other companies offered their unique takes on the biosimilar draft guidance from the EMA, calling for more clarity and some new additions before the final draft takes effect.
Ranbaxy Laboratories has launched the monoclonal antibody Infimab, the first Remicade (Infliximab) biosimilar, in India -- which is the first what could be a few home-grown biosimilar launches.
Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”
Amgen has completed construction of its first $200m next-gen biomanufacturing facility in Singapore, which is outfitted with single-use technology to allow for greater flexibility.
Like the US and EU, China’s SFDA is looking to ensure that approved biosimilars are proven to be similar to their reference drugs, according to an unofficial translation of the guideline by BioCentury.
The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.
Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week.
Despite plans to lay off more than 2,000 employees, Amgen is preparing for a biosimilar onslaught and expanding its portfolio to nine biosimilar programs.
Eli Lilly’ manufacturing network will give it the edge in the glargine insulin market, the firm says having received tentative approval of its “Lantus look-alike” from the USFDA.
A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.
Amgen is reviewing data from chronic kidney disease (CKD) patients to assess what impact switching to a 'biosimilar' version of its blood cell booster Aranesp (Darbepoetin Alfa) has had on their disease.
Biomanufacturing costs and the risk of extractables and leachables can be reduced by developing more compatible plastics, Sabic told Biopharma-Reporter.com at CPhI in Paris.
