Biosimilars

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

Business briefs: Biosimilars, Johnson & Johnson, Consumer Reports

FDA is concerned state biosimilar legislation could make consumers uneasy about the category, J&J hands $75 million milestone payment for ibrutinib, Consumer Reports gets into drug apps

Business briefs: Medtronic, Novo Nordisk, plus OIG's latest probe

Medtronic buys up Cardiocom, Novo will file liraglutide to battle obesity, HHS navigates cutback and looks into anti-psychotic prescription rates, Amgen's Neulasta to compete against Teva's Lonquex.

Business briefs: Glaxo, Teva, Johnson & Johnson

Glaxo shakes up China division, Teva and Lonza break up their biosimilars pact, and FDA's breakthrough designation speeds review but not international and payer uptake.

GA101 looks more like a franchise-extender for Roche

By

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.

Roche's son-of-Rituxan scores priority review

By

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.

EU backs Remicade biosimilars; anti-TNFs at risk

By

CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.

Sandoz readies Enbrel biosimilar for testing

By

The drug maker says it expects to use the Phase III clinical trial data to back applications in the EU and the US (when it gets a pathway setup).

Study shows old-school meds as effective as Enbrel

By

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.

Roche's Rituxan successor receives high marks

By

Genentech's blockbuster follow-up shows promise in preliminary Phase III data

AbbVie reports first-ever quarter, downplays Pfizer impact

By

Humira led in sales and the company told analysts Pfizer's Xeljanz setback in Europe won't alter its RA future all that much.

Pharmas to biotechs: let's make a deal

Pharmas to biotechs: let's make a deal

By

Having finally accepted that external R&D is the future, big pharmas are snapping up earlier-stage biotechs and biologics, but they're not betting the farm on them, thanks to pre-nup-like earnout deals.

Amgen sales up for the quarter, but biosimilars grab buzz

By

Company revenues were up 5% over last year for the quarter, but much of the Q&A chatter centered around biosimilars.

Q&A: BIO's Jim Greenwood

Q&A: BIO's Jim Greenwood

By

BIO chief Jim Greenwood talks policy priorities and previews the group's International Convention, now underway in Chicago.

Business Briefs: AstraZeneca, Amgen, BMS and Merck

AstraZeneca cuts a deal with OCB to test unnamed cancer drug; an Enbrel biosimilar launches in India; BMS and Santaris seal an mRNA tech deal; Merck expands its China presence; Alzheimer's advocacy group parents a spin-off.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.