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Teva Lawsuit Labels The IRA A ‘Fiction’ As Austedo Opens Up To Price Negotiations

Pricing Scheme ‘Hurts Generics And Biosimilars, Weakens Whole Healthcare System’

 
• By Dean Rudge

Teva has filed a complaint in Washington D.C. challenging certain aspects of the drug-pricing provisions of the Inflation Reduction Act as well as Centers for Medicare & Medicaid Services guidance, claiming that the statute will disrupt the balance of innovation and affordability.

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Teva cited its “unique position as a developer of innovative medicines and high-quality generic drugs and biosimilars,” as it sued the US Centers for Medicare & Medicaid Services challenging certain aspects of drug-pricing provisions within the Inflation Reduction Act, which the Israeli firm declares “hurts not just the manufacturers of generics and biosimilars, but also weakens the US healthcare system as a whole.”

Meanwhile, in its suit Teva also attacked guidance issued by the CMS that, the firm says, “purports to implement” the IRA, “re-writing two of the critical limitations imposed by Congress...

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Amgen And Samsung Soliris Biosimilars Skirt UK Infringement On Claim Construction

 
• By Dean Rudge

Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.

Aurobindo, MSN Fall To US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.

J&J Hits Back Over Private-Label Stelara Biosimilar In US

 
• By Dave Wallace

After being refused an injunction as part of ongoing litigation over a private-label ustekinumab biosimilar being marketed in the US by Sandoz and Samsung Bioepis, Stelara originator Johnson & Johnson is continuing to pursue an appeal. However, newly-unsealed court documents suggest the brand company had demonstrated a likelihood of success - and reveal further details about the case, including the identity of the PBM involved and why the injunction request was denied.

Amgen Locked Out Of Canadian Eculizumab Market Until 2027

 
• By Dean Rudge

Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.

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Formycon Hopes Stelara Biosimilar Sales To Pull Through FY2025 As Q1 Revenues Slump

 
• By Urtė Fultinavičiūtė

Formycon said it predicted low earnings in the first quarter of 2025, after enjoying milestone payments last year. Now, the pressure is on the growing biosimilars portfolio to pull the company through this year.

Gedeon Richter Feels Biosimilar Model ‘Is Looking For An Equilibrium’

 
• By Dean Rudge

Gedeon Richter’s CEO weighed in on the pricing landscape for biosimilars as the firm admitted the market for biosimilar denosumab was set to be more crowded than it had initially anticipated.

Lupin CEO On Trump’s Most Favored Nation Policy, Tariffs, Firm’s Five-Year Plan

 
• By Vibha Ravi

Lupin CEO Vinita Gupta speaks on Trump’s most favored nation policy, the Inflation Reduction Act’s “pill penalty” and other developments in the US, a major market for the company. The company also outlines a five-year plan focused on complex generics and technology platforms.