Opinion: Improving the FDA-EMA parallel scientific advice program to advance complex generics
Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly…
Category: Biosimilars
Opinion: PBMs aren’t opening access to lower-cost biosimilars. Reform is needed now
The Federal Trade Commission presents on Thursday its interim staff report, “Pharmacy Benefit Managers: The Powerful…
STAT+: Thanks to CVS, a biosimilar version of AbbVie’s Humira is grabbing huge market share
The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment,…
STAT+: Boehringer Ingelheim layoffs are a sign of dysfunctional Humira biosimilar market
WASHINGTON — Boehringer Ingelheim is laying off or relocating its sales staff for its Humira biosimilar…
Virtual Event: March of the Biosimilars
Editor’s note: A livestream of this event will be embedded below at 1 p.m. ET….
Opinion: STAT readers on what human health care can learn from veterinary medicine and more
STAT now publishes selected Letters to the Editor received in response to First Opinion essays…
Opinion: STAT+: A year in, the U.S. is still not taking advantage of lower-cost biosimilars for Humira
It’s been one year since the launch of the first adalimumab biosimilar for Humira in…
Opinion: STAT+: The problem with potential changes to the biosimilar regulatory framework
Biosimilars are no longer a new and untested class of medicines. Today, they provide critical…
STAT Virtual Event: The State of Biosimilars: What to Watch
Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET. Now…
STAT+: Pharmalittle: Eisai exec who helped lead Alzheimer’s drug development to retire; Express Scripts adds three Humira biosimilars to preferred formulary
Top of the morning to you, and a fine one it is. Birds are chirping…
STAT+: Pharmalittle: PBMs are targeted in yet another congressional bill; access to new Alzheimer’s drug may not happen quickly
Rise and shine, another busy day is on the way. However, this is also shaping…
STAT+: Coherus works with Mark Cuban to sell biosimilar Humira at steep discounts
In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira —…
STAT+: Supreme Court rules against Amgen in closely watched case over scope of patent claims
In a case that had the pharmaceutical industry on edge, the U.S. Supreme Court upheld…
STAT+: Amgen pricing for its Humira biosimilar may benefit PBMs and insurers more than patients
Underscoring the opaque and confusing nature of pharmaceutical pricing, Amgen announced long-awaited pricing for its…
Opinion: A watershed year for biosimilars — if regulators and policymakers step up
January 31 is set to mark the start of a watershed year for the biosimilars…
Opinion: To protect the medical supply chain, ‘made in America’ will be key
The Covid-19 pandemic exposed a serious flaw in the United States’ medical supply chain: an…
STAT+: ‘Skinny labels’ on biosimilar medicines saved Medicare $1.5 billion over a recent five-year period
A hotly contested provision of a federal law designed to speed copycat drugs to market…
Opinion: STAT+: Removing barriers to biosimilar adoption in the United States
Biosimilars, a much-lauded approach to reducing drug costs in the United States, are still underused…
Virtual Event: Biosimilars’ Meteoric Moment
Editor’s note: A livestream of the conversation will be embedded below at 1 p.m. ET….
Opinion: Market share isn’t the only metric for biosimilars’ success
Market share is often held up as the most relevant metric for the success of…
STAT+: U.S. appeals court panel decides AbbVie’s ‘patent thickets’ for Humira don’t thwart competition
In a significant victory for AbbVie, a U.S. appeals court panel declined to revive a…
STAT+: Medicare Part D and its beneficiaries could have saved millions if more biosimilars were accessible
Amid ongoing debate over biosimilar use in the United States, a new government analysis found…
STAT+: AbbVie settles litigation with another drug maker over a biosimilar version of Humira
After months of squabbling over allegedly stolen trade secrets, AbbVie (ABBV) has settled litigation with…
STAT+: FDA approves an interchangeable biosimilar version of Humira, but health care savings are dubious
For the first time, U.S. regulators have approved an interchangeable, biosimilar version of Humira, a…
Opinion: Biosimilars competition helps patients more than generic competition
Much of the current drug-pricing agenda proposed by President Biden and by Congress is based…
STAT+: AbbVie loses a lawsuit over Humira trade secrets it claimed were stolen
In a setback to AbbVie (ABBV), a U.S. federal court judge dismissed a lawsuit in…
Opinion: FDA’s naming rule for biosimilars has undermined Congress and health care
I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of…
Virtual Event: The evolving landscape for biosimilars
Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET….
Biosimilar drugs gain ground in U.S., but concerns linger about when patients can switch
It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal…
Biosimilar drugs gain ground in U.S., but concerns linger about when patients can switch
It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal…
Opinion: The FDA just broke the logjam on interchangeable biologics. Here’s what that decision means
The Food and Drug Administration’s decision on Wednesday to approve a long-acting insulin called Semglee…
STAT+: FDA approves the first interchangeable biosimilar insulin. Will it really lower the cost?
In a long-awaited move, the Food and Drug Administration has approved the first so-called interchangeable…
STAT+: FDA scolds Amgen over a misleading ad that could deter use of biosimilar versions of its drug
In an embarrassing rebuke, the Food and Drug Administration has scolded Amgen (AMGN) over a…
Opinion: STAT+: Three steps toward creating a functioning U.S. biosimilars market
The development of safe, effective, and innovative biologic medicines is one of modern medicine’s far-reaching…
STAT+: AbbVie accuses a company of recruiting an employee in order to steal Humira secrets
Two years ago, a manufacturing team leader at AbbVie (ABBV) took a similar job at…
STAT+: Once again, the viability of the U.S. biosimilar market is thrown into question
Despite periodic reports that biosimilars have finally arrived and will save the U.S. health care…
STAT+: In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition
Arguing the Food and Drug Administration is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has…
STAT Plus: Mylan launches a low-cost biosimilar insulin, but experts say many patients may not save on costs
Amid a national outcry over the cost of insulin, one of the largest generic companies…
STAT Plus: Tiny Denmark saved lots of money on biosimilar Humira, while Americans are still paying big bucks
For those yearning for the day when biosimilars save the U.S. health care system huge…
STAT Plus: Biosimilars got the cold shoulder from health plans when it came to preferred coverage
As debate rages over adoption of biosimilars in the U.S., a new analysis finds that…
STAT Plus: Large employers could have saved money if more biosimilars had been prescribed
If some of the largest U.S. employers had used biosimilar versions of a pair of…
Opinion: Biosimilars could disappear if the Supreme Court overturns the ACA
With the sense of urgency rightly focused on slowing or stopping the spread of Covid-19,…
Opinion: Five years on, biosimilars need support from all health care players
Today marks a milestone for the U.S. biosimilar market: the FDA approved our first biosimilar,…
Opinion: From bench to bedside, biologics require excellence at every stage
The Nobel Prize in Medicine will never be awarded for excellence in the formulation and…
STAT Plus: Insulin makers object to FDA proposal for speeding arrival of biosimilar insulins
Amid growing rancor over the cost of insulin, two of the largest manufacturers are objecting…
STAT Plus: FDA and FTC vow to attack anti-competitive practices that limit biosimilar uptake
As frustration mounts over the slower-than-expected uptake of biosimilars in the marketplace, two U.S. federal…
STAT Plus: Airing frustrations with pharma, a Republican FTC commissioner just endorsed Medicare negotiation
WASHINGTON — A Republican member of the Federal Trade Commission on Thursday expressed support for…
STAT Plus: Generic makers will appeal ruling that allows California to proceed with law banning pay-to-delay deals
A federal judge dealt the pharmaceutical industry a setback by declining to block a new…
STAT Plus: More hospital drug spending is going toward cancer immunotherapies
Amid intense scrutiny over prescription drug costs, a new analysis finds some hospitals are spending…
STAT Plus: Pharmalittle: China to bulk-buy to lower drug costs; Senate bill to tackle drug prices going nowhere fast
Good morning, everyone, an welcome to another working week. We hope the weekend respite, which…