Biosimilars

Doctors want specifics on biosimilar labels

An Alliance for Safe Biologic Medicines survey shows what doctors mean by biosimilar transparency.

Five things for pharma marketers to know: Friday, March 20

Five things for pharma marketers to know: Friday, March 20

By

A judge rules against Amgen in Neupogen case; FDA advisory panel recommends Breio Ellipta for adults with asthma; AstraZeneca partners with Daiichi Sankyo to sell Movantik

Biosimilar uptake will require companies to tell a trustworthy backstory

Biosimilar uptake will require companies to tell a trustworthy backstory

By

Reactions to the first biosimilar approval show that marketing and education will be essential for the new category to take market share.

FDA hands Amgen a biosimilar competitor

FDA hands Amgen a biosimilar competitor

By

The regulator approved Novartis's Neupogen lookalike. Amgen, which markets Neupogen, has a trove of its own potential biosimilars.

Five things for pharma marketers to know: Friday, March 6

Five things for pharma marketers to know: Friday, March 6

By

FDA approves the first biosimilar, judge rules that FDA panel members had conflicts of interest, and a new venture will evaluate the effectiveness of digital health technologies.

Tufts: biosimilars will not be an instant hit

A study by the nonprofit research group found resistance to drug switching.

Lilly Lantus biosimilar to hit EU

The EU will have access to the new medication in May.

Five things for pharma marketers to know: Monday, February 9

Five things for pharma marketers to know: Monday, February 9

By

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's Hospira deal shores up established product division

Pfizer's Hospira deal shores up established product division

By

Pfizer said the $17-billion decision to acquire Hospira will not affect the timeline of its divide-or-stay-whole decision.

Five things for pharma marketers to know: Wednesday, February 4

Five things for pharma marketers to know: Wednesday, February 4

By

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.

Five things for pharma marketers to know: Tuesday, January 20

Five things for pharma marketers to know: Tuesday, January 20

By

FDA draws fine line between health and wellness apps; Colorado gives biosimilar swap law another look; ZMapp is set to start human trials of its Ebola vaccine.

FDA panel to weigh first biosimilar application

FDA panel to weigh first biosimilar application

By

The committee is slated to rule on Sandoz's Zarzio Jan 7.

FDA plans review of Sandoz's Neupogen biosimilar

As courts sort out lawsuits over two Sandoz biosimilars, the Novartis unit reports a study showing its BLA candidate has similar efficacy to Neupogen.

Amgen releases Humira biosimilar data

The company says ABP 510 hit its primary endpoint in an adalimumab comparison.

FDA kind of OKs Lilly/BI's Lantus look-alike

FDA kind of OKs Lilly/BI's Lantus look-alike

By

Sanofi's patent lawsuit triggered the tentative approval of the Lilly-BI Lantus competitor.

Doctors back unique biosimilar names

A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.

Investors want end to biosim trash talk

A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.

Senators ask FDA for biosimliar naming rules

Soonish would be good, since a Novartis subsidiary filed a biosimilar with the FDA last month.

FDA to review Neupogen biosimilar

Novartis subsidiary Sandoz announced Thursday that the FDA has agreed to review its filgrastim biosimilar which is already approved in 40 countries.

Insurers put in bid for biosimilar naming

Health insurers and pharmacies signed a letter asking the FDA to require biosimilars and branded biologics to share the same name.

FDA seeks math of similarity

A three-year, $1 million project seeks an equation for generics and biosimilars.

UK court OKs Herceptin biosimilar

A London court knocked down two Roche/Genentech patents, making a clearer path for biosimilars of the breast cancer drug. The primary patent lapses in July.

Merck latest rival in race to copy Lantus

Merck latest rival in race to copy Lantus

By

Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.

Roche silences Herceptin comparison

A court in India ruled biosimilar drug makers will not be able to cite the drug's name, efficacy or safety profile in its marketing.

Must biosimilar names be distinct? No, experts argue

Must biosimilar names be distinct? No, experts argue

Innovator companies want the FDA to adopt separate names for biosimilars. Manufacturing changes aren't drastic enough to make it necessary, experts argued at an FTC workshop.

Sandoz wades into Humira biosimilars

The generics maker says an adalimumab biosimilar would anchor its immunology portfolio.

Biogen Idec pursues anti-TNF biosimilars

Biogen Idec pursues anti-TNF biosimilars

By

Biogen Idec and JV partner Samsung are going into the biosimilars business.

Doctors to resist uptake of biosimilar insulins: report

Doctors to resist uptake of biosimilar insulins: report

By

Lantus-like rivals can expect a wary reception from endocrinologists, even if these biosimilars reach market, researchers predict.

Calif. governor vetoes biosimilars bill

The governor says it is too early to legislate on drugs the FDA is still deliberating over.

Business briefs: Biogen, Celgene, J&J, plus Obamacare TV push

Biogen extend Isis relationship for six years and $100M; HHS readies healthcare reform TV push; Medivir ends hep. B clinical trial; FDA approves Celgene cancer drug; Baxter seeks Enbrel biosimilar

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.

Email Newsletters