Eli Lilly and Boehringer Ingelheim received approval to begin selling their Lantus knock-off drug after settling a patent lawsuit with Sanofi in September.
The FDA approves Lilly's Lantus follow-on biologic; AstraZeneca buys majority stake in Acerta Pharma; Shkreli arrested on securities fraud charges
The health insurance industry's trade association, along with other organizations, sent a letter to the FDA arguing that different names could lead to prescriber confusion and medication errors.
Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting
About 80% of polled dermatologists told Leerink Partners they would likely prescribe the experimental biologic dupilumab.
The documents acknowledge biosimilars and branded biologics will differ and set assessment standards.
Celltrion expects its Remicade biosimilar to hit the US this year; Vivus cuts its sales force; BMJ accuses Novartis of interfering with clinical trials
An Alliance for Safe Biologic Medicines survey shows what doctors mean by biosimilar transparency.
Reactions to the first biosimilar approval show that marketing and education will be essential for the new category to take market share.
The regulator approved Novartis's Neupogen lookalike. Amgen, which markets Neupogen, has a trove of its own potential biosimilars.
A study by the nonprofit research group found resistance to drug switching.
Achillion's experimental HCV drug cleared the virus in six weeks when combined with Gilead's Sovaldi; Sanofi will replace a third of its sales managers; GSK shutters Montana vaccine R&D.
Pfizer said the $17-billion decision to acquire Hospira will not affect the timeline of its divide-or-stay-whole decision.
One in three adults would rather not take a pill and have a shorter life span; Pfizer's next-gen breast-cancer drug nabs an early approval; Amgen's Humira biosimilar demonstrates clinical equivalence.
A novel psoriasis treatment approved today, which demonstrated superiority to TNF inhibitors, could unseat entrenched competitors like Amgen's Enbrel and J&J's Stelara.
Severe flu season to test Roche's Tamiflu; Novartis gains nod for psoriasis drug; Amgen and Kite collaborate on immunotherapy.
A look at the content that grabbed most reader interest over the past year.
As courts sort out lawsuits over two Sandoz biosimilars, the Novartis unit reports a study showing its BLA candidate has similar efficacy to Neupogen.
The company says ABP 510 hit its primary endpoint in an adalimumab comparison.
Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.
A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.
Soonish would be good, since a Novartis subsidiary filed a biosimilar with the FDA last month.
The generics maker says an adalimumab biosimilar would anchor its immunology portfolio.
The governor says it is too early to legislate on drugs the FDA is still deliberating over.
Sales may be rising, but a new study finds current psoriasis therapies leave room for improvement. Over half of patients said they want better options.
The interim results of a Phase III study augur well for use of Roche's Rituxan successor in more than one type of leukemia, one analyst said.
The FDA's priority review for the Phase III chronic lymphocytic leukemia drug comes on top of Breakthrough Therapy designation, which the agent won in May.
CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.
A cocktail of older meds works as well as Enbrel, a study found, but docs are already comfortable with prescribing the biologic and aren't likely to switch therapies.
Humira led in sales and the company told analysts Pfizer's Xeljanz setback in Europe won't alter its RA future all that much.
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