Sentences with word «biosimilar»
The word "biosimilar" refers to a medication that is designed to be highly similar to another medication that is already approved and used for treating a specific illness. Biosimilars are intended to have the same effectiveness and safety as the original medication, but they may be available at a lower cost. Full definition
Alice Klein notes some clinicians» concerns about the safety and efficacy of biosimilar versions of biological drugs compared with the...
newscientist.com
That could spell further trouble for Rituxan manufacturer Roche, which has seen a number of companies win European approval for biosimilars of some of its best - selling products.
Pfizer is trying to expand its presence in biosimilar (not generic) drugs, which Hospira can provide.
The Food and Drug Administration (FDA) has not yet issued guidelines for licensing biosimilar products in the United States; biotechnology patent attorneys must nevertheless be prepared to review information from FDA and USPTO and to advise clients without these guidelines.
«Rigged» Pricing, Contracting and Rebate «Schemes,» and Drug Pricing «Shell Games:» FDA Commissioner Scott Gottlieb Lets Loose on the U.S. Biosimilar Market While Offering Peek at New Policies
Signed into law on March 23, 2010, the BPCIA creates a regulatory pathway for the approval of biosimilar drugs in the United States and a mechanism, albeit voluntary, for resolving patent right disputes relating to the innovator biologic products.
The FDA just approved the first biosimilar drug for market.
Skills in the biological sciences and the law help attorneys understand what the new U.S. biosimilar law means and how it is likely to be applied.
Further studies are now planned with biosimilar - treated patients to better assess the potentially different immune responses associated with biologics.
Without it, Lilly is counting on other fresh market entries to pick up the slack, including diabetes drug Jardiance and Basaglar, its new biosimilar version of Sanofi's insulin blockbuster Lantus.
In the pharma sector, we expect the development of next - generation platforms such as biosimilars and gene therapy to accelerate.
MVASI is the first anti-cancer biosimilar approved by the FDA, and it is also under review by the European Medicines Agency (EMA).
On March 22nd at 12 p.m. ET, Dean Fanelli and Jamaica Szeliga, along with Timothy Shea of Sterne, Kessler, Goldstein & Fox P.L.L.C., will present a live webcast on Biosimilar Litigation and Your BPCIA Compliance: Key Strategies In Light of AbbVie v. Boehringer.
The first Biosimilar approval in March 2015 per the new FDA pathway highlights several issues.
He criticized the health industry for failing to promote access to so - called biosimilar versions of drugs, and for pricing practices that harm consumers.
That law requires biosimilar makers to give a six - month notice of sales to rivals.
Advisory panels to the Food and Drug Administration (FDA) this week gave unanimous recommendations for so - called biosimilars of Humira and Enbrel developed by Amgen and Novartis (nvs) generics unit Sandoz, respectively.
It's also much cheaper than a previous Remicade biosimilar from Pfizer (pfe) that's available at a 15 % discount to Remicade.
In addition, the company did a good job protecting its top - selling drug, Remicade, from biosimilar competition while also enjoying strong sales growth for products like Darzalex and Stelara.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions.
New FDA regulatory pathways may be required, aside from the new Biosimilar pathway, given the need for clinical trials.
ew data presented today at the European League Against Rheumatism Annual Congress (EULAR 2014) show that the newly - approved infliximab biosimilar CT - P13 achieves statistically similar improvements in disease activity, disability and mobility in patients with Ankylosing Spondylitis (AS) compared to its original reference product infliximab (INX).
Deutsche Bank analyst Tim Race said Rituxan could now remain free from biosimilar...
The current biosimilars landscape is in stark contrast to the generics market where payers and pharmacy benefit managers promote these cheaper alternatives to reduce healthcare costs.
However, the incidence of the ADA and their magnitude of impact on the clinical response or adverse event were similar between biosimilar CT - P13 and innovator infliximab.
«Biosimilar CT - P13 matches infliximab in improving ankylosing spondylitis disease activity.»
The new health - care legislation contains a provision that gives the makers of biologics 12 years of patent protection before other companies can produce biosimilars.
I recently organized a conference and wrote a treatise on the new biosimilar law, which shows that a career as a patent attorney offers opportunities similar to those offered by a career in academic science.
Pharmaceutical companies are concerned about an onslaught of legislative proposals percolating in state houses around the country, among them: changes to Medicaid programs to rein in the high cost of prescription drugs, intellectual property issues, and the fight over biosimilars.
That will provide a new revenue stream, which should grow as other biosimilars now in the pipeline come to market.
Novartis has several more biosimilars marketed in other countries (as well as an FDA approved copycat of Amgen's bestselling treatment Enbrel, which hasn't reached the U.S. yet due to patent spats), and three others in late - stage clinical development.
«While America's rheumatologists support the development of new biosimilar therapies, the safety of our patients remains our highest priority.
We assemble Global Biotech Veterans to lead the Cell Line Construction, Process Development, Manufacturing, Quality & Regulatory Teams to produce cost effective biosimilar & biologics through innovative technology & efficiency improvement.
The special 4 letter suffix is said to be unnecessary and decrease Biosimilar uptake.
The Amgen / Sandoz biosimilars case heads to the Supreme Court.
The FDA is slated to make its decisions on the Humira and Enbrel biosimilars by the end of the year.
Labeling rules are currently under review and will affect how Biosimilars are accepted / characterized in the marketplace.
For example, Amgen has challenged Novartis in court over its Enbrel copycat, even as it chases its own approval for biosimilar Humira.
The FDA is still finalizing regulatory decisions about the products and only approved the first U.S. biosimilar last year, Novartis» (nvs) copy of Amgen's (amgn) Neupogen, called Zarxio.
I think legislative clarity would give both innovator and biosimilar companies more certainty and would save both sides money that could be invested in additional research to help save lives.
Sales of that flagship treatment fell 8.2 % while sales of generics and biosimilars fell 13.5 %.
«We'll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA's rigorous gold standard for safety and effectiveness.»
It's still unclear just how much biosimilars may reduce drug spending in the U.S. Inflectra's makers have reportedly mulled a 20 - 30 % discount over branded Remicade, and discounts have been even steeper in Europe.
Novartis and Amgen are actually key players in this battle, with a separate legal case over when biosimilar makers must give their branded counterparts a six - month notice heading to the Supreme Court.
There are still a number of unresolved legal issues surrounding biosimilars, which have only been around in the U.S. since 2015.
Since biosimilars are so new to the U.S. market (there have been just five total approved here since 2015), it's been hard to gauge whether or not they can make a formidable dent in high drug prices by offering generic alternatives to branded treatments.
Samsung's Bioepis arm has been on a quest to create biosimilars — or copycats of biologic drugs that are usually priced at deep discounts — of some of the world's top therapies.
The agency also approved a different Remicade biosimilar just last month from South Korea's Celltrion and its U.S. partner, Pfizer (pfe).