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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Goodwin

Lupin and Zentiva Reach Agreement to Commercialize Certolizumab Pegol Biosimilar

Goodwin on

On July 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin’s biosimilar of Certolizumab Pegol across multiple global markets. ...more

Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated January 13, 2025

Rothwell, Figg, Ernst & Manbeck, P.C. on

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

A&O Shearman on

The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

Faegre Drinker Biddle & Reath LLP on

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.75

Jones Day on

COMPETITION & STATE AID - State Aid- Fit for Future Platform pursues simplification of EU law, including Opinion on State aid - On 28 January 2022, the Fit for Future Platform, a high-level expert group to assist the...more

Goodwin

EMA Reviews Samsung Bioepis’ Lucentis Biosimilar For Eye Diseases

Goodwin on

Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an...more

Goodwin

Sanofi’s Insulin Aspart Biosimilar Receives EMA Authorization

Goodwin on

Last week, the EMA authorized Insulin aspart Sanofi’s biosimilar product. The EMA notes on its website that Insulin aspart Sanofi is “highly similar to another biological medicine [NovoRapid] that is already authorized in the...more

Goodwin

Biosimilars Approvals: Nepexto Receives European Marketing Authorization, Ziextenzo and Riximyo Receive Health Canada Approval

Goodwin on

Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows...more

Goodwin

Celltrion to Launch REMSIMA SC (infliximab) in Europe in March, 2020

Goodwin on

Multiple sources are reporting that Celltrion is planning to roll out REMSIMA SC, its subcutaneous infliximab biosimilar of Johnson & Johnson’s autoimmune disease treatment REMICADE, in Europe in the first quarter of 2020,...more

Robins Kaplan LLP

Financial Daily Dose 1.24.2020 | Top Story: OCC Hits Former Wells Fargo Execs With Enforcement Actions Over Sham-account Scandal

Robins Kaplan LLP on

The OCC announced yesterday that it’s bringing enforcement actions against five former Wells Fargo bank executives as part of their alleged roles in the bank’s sales practices scandal. The agency further revealed that it’s...more

Goodwin

Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Goodwin on

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets....more

Womble Bond Dickinson

Higher than expected European Medicines Agency staff losses will impact its business continuity plan

Womble Bond Dickinson on

The EMA will be launching Phase 3 of its business continuity plan on October 1, 2018 at the latest, however, the detail of the plan will now be impacted by the EMA announced this week that it has realized that it will lose...more

Hogan Lovells

Patent law in Europe: What pharmaceutical companies need to know

Hogan Lovells on

Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more

Hogan Lovells

UK publishes paper on Brexit and medicines regulation

Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

Searcy Denney Scarola Barnhart & Shipley

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

Searcy Denney Scarola Barnhart & Shipley on

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

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