On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s biosimilar of low dose (2 mg) EYLEA (aflibercept)....more
The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024....more
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab....more
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
On January 10, Alvotech announced that the European Commission (EC) issued a marketing authorization to its European commercialization partner, STADA, for UZPRUVO (AVT04), a biosimilar referencing STELARA...more
As previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after...more
On July 14, Dong-A ST announced that the European Medicines Agency accepted its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar referencing STELARA (ustekinumab). STELARA is approved for the treatment of...more
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more
Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe - On November 14, Stelis Biopharma Limited (Stelis), the biologics arm of Strides Pharma Science Limited, announced that its first...more
Biogen Inc. (“Biogen”) recently announced that the European Medicines Agency (EMA) has accepted the marketing authorization application for BIIB800 (BAT1806), a biosimilar candidate referencing Roche’s ACTEMRA...more
On September 19, 2022, the European Medicines Agency (EMA) and the Heads of Medicines’ Agencies (HMA) issued a joint statement explaining their scientific rationale for determining that biosimilars approved in the EU...more
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently adopted positive opinions for three biosimilar products. On June 23, 2022, CHMP recommended the grant of a marketing...more
On May 19, 2022, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued opinions recommending the refusal of marketing authorization for Prestige BioPharma Ltd.’s HD201, TUZNUE and...more
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab). Humira®...more
On 24 September 2020, the European Medicines Agency (“EMA”) published a draft Guideline on registry-based studies. The EMA’s intention is to enhance the use of registry-based studies as a source of real-world evidence (RWE)....more
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
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
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more
The European Medicines Agency (EMA) has announced that it now offers the possibility for simultaneous review of centralized marketing authorization applications (MAAs) and applications for a scientific opinion under Article...more
Fresenius Kabi announced on May 27, 2020 that the FDA “accepted for review the company’s Biologics License Application (BLA) for MSB11455,” a biosimilar candidate of NEULASTA (pegfilgrastim). According to the press release,...more
On April 30, 2020, Sanofi received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use (CHMP), recommending the granting of marketing authorization for its biosimilar of...more
In late October 2019, the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) of the Heads of Medicines Agencies (HMA) published a practical guidance on nitrosamines. The guidance is...more
On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in therapeutic indications. The...more
A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more