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FDA transitions to new regulatory pathway for biosimilars
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
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Biosimilars
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FDA announces changes that will soon affect compounders
A change to the law will soon be impacting compounding of certain products beginning on 23 March 2020 the US Food and Drug Administration (FDA) has announced.
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How will the rise of biosimilars impact biologics?
Once patents expire for biologic medicines, a market opportunity opens up for biosimilars, a cheaper alternative. With more patents due to expire soon, what will the future look like for biologic medicines?
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How developments in the pharmaceutical sector are impacting logistics
There are currently major seismic shifts happening in the pharmaceutical sector that are disrupting the status quo. Some of the most notable changes are the rise in biosimilars, the downward pressure on pricing, increased global spending and advances in technology, all of which are impacting the logistics sector and affecting…
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The FDA and FTC team up to prevent anti-competitive practices
The two agencies have signed a statement of their intent to combat anti-competitive practices which are preventing the adoption of biosimilars in the US drug market.
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Biologics patent expiry to positively impact US pharma, says report
New research has suggested that the expiration of biologics patents will be the factor that positively impacts US pharma the most this year.
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The intricacies of rising drug prices in the US
Following 250 US drug price increases in 2020 already, this article explores why costs are rising, what changes could ensure brand reputations remain intact and what manufacturers can do to ensure they get their share.
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WHO announces first biosimilar medicine pre-qualification
A trastuzumab biosimilar has been pre-qualified by WHO, marking its first, to improve access to the breast cancer treatment.
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Generics and biosimilars vital to reduce healthcare costs, finds EC
The EC has released a report that has found generics and biosimilars decrease wasteful spending and maintain health quality in the EU.
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EU marketing authorisation granted for rheumatoid arthritis treatment
Remsima SC™ is the world’s first subcutaneous formulation of infliximab and has been approved in the EU for the treatment of people with rheumatoid arthritis.
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Ziextenzo™ biosimilar has received approval from the FDA
The FDA has approved Sandoz's biosimilar Ziextenzo and the company now intends to launch it in the US as soon as possible this year.
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Terrosa® osteoporosis biosimilar treatment launched in Europe
A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.
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Amgen wins court patent ruling over Sandoz biosimilar
The US District Court has decided in favour of Amgen’s Enbrel, ruling over Sandoz’s Erelzi in a patent conflict.
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FDA antibody biosimilar product approvals increase in 2019
2019 has seen a marked increase of antibody biosimilar product approvals in the first half of the year, according to a report.
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RUXIENCE™ biosimilar granted approval from FDA
The FDA has approved RUXIENCE (rituximab-pvvr), a biosimilar to Rituxan® (rituximab), for treatment of non-Hogkin’s lymphoma and other conditions.
