European Pharmaceutical Review

JANUARY 11, 2024

The European Commission (EC) has granted a marketing authorisation for Uzpruvo ® (AVT04) in Europe, a biosimilar candidate to Stelara ® (ustekinumab). A new European biosimilar approval “This first marketing authorisation for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition.

Biosimilars 103

Biosimilars Immunity Immunization 103

Outsourcing Pharma

FEBRUARY 6, 2024

Rani Therapeutics, a clinical-stage biotherapeutics company focused on the oral delivery of biologics, has announced encouraging results from its phase 1 study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43.

Biosimilars 112

Biosimilars 112

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Sustainable biosimilar competition in Europe: can it be achieved? Stelara biosimilars in the US market The first Stelara biosimilars are expected to enter the US market in 2025. “We

Biosimilars 92

Biosimilars 92

Express Pharma

NOVEMBER 9, 2023

USV and Biogenomics announced the launch of INSUQUICK, biosimilar Insulin Aspart. A company statement informed, “InsuQuick is a “Make in India” product, developed and manufactured using 100 per cent indigenous technology, and has undergone a robust clinical program to ensure global quality standards.

Biosimilars 104

Biosimilars Diabetes 104

European Pharmaceutical Review

SEPTEMBER 11, 2023

has entered into an agreement with Sandoz to commercialise SB17, a proposed biosimilar to Janssen Pharmaceuticals’ Stelara ( ustekinumab ). About the biosimilar development deal This agreement will help to expand access to biosimilar medicines , according to Samsung Bioepis. Samsung Bioepis Co.,

Biosimilars 78

Biosimilars 78

European Pharmaceutical Review

AUGUST 16, 2023

Sandoz has announced positive results from the MYLIGHT Phase III study for its biosimilar aflibercept, for patients living with wet macular degeneration. The confirmatory efficacy and safety study ( NCT04864834 ) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®.

Biosimilars 96

Biosimilars Diabetes 96

Integra X Files

APRIL 3, 2023

Drugs vs. Biologics: What’s the Difference If you ask a layperson about biosimilars, you are likely to hear comparisons to generic drugs, and that would not be completely wrong. Biosimilar products are not drugs and they are not generic, in the sense that they’re not identical to the reference product.

Biosimilars 78

Biosimilars Drug Pricing 78

European Pharmaceutical Review

APRIL 6, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EPYSQLI , a biosimilar referencing Soliris (eculizumab), also known as SB12. We are pleased to see EPYSQLI becoming our first biosimilar in haematology to be recommended for approval in Europe.

Biosimilars 92

Biosimilars 92

European Pharmaceutical Review

NOVEMBER 15, 2022

The International Generic and Biosimilar Medicines Association (IGBA)’s new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline suggests how the guideline provides great opportunity to revaluate how regulatory requirements can better advance biosimilar access.

Biosimilars 93

Biosimilars Documentation 93

European Pharmaceutical Review

SEPTEMBER 20, 2022

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. Interchanging biosimilars is an acceptable practise already used by many Member States.

Biosimilars 93

Biosimilars Diabetes 93

Express Pharma

JANUARY 2, 2024

Glenmark Pharmaceuticals has launched a biosimilar of anti-diabetic drug, Liraglutide, in India. Clinical trials on Indian adult patients with type 2 diabetes mellitus over a 24-week period have demonstrated Lirafit to be effective, safe and well-tolerated. It is priced at around Rs 100 for a standard dose of 1.2 mg (per day).

Diabetes 99

Diabetes Biosimilars 99

Pharmacy Times

OCTOBER 18, 2023

Following the results of a meta-analysis that reviewed biosimilar trial design and endpoints, investigators urge for greater biosimilar uptake initiatives.

Biosimilars 52

Biosimilars 52

Big Molecule Watch

SEPTEMBER 28, 2023

Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the U.S. Oncology, Women’s Health, and Respiratory Disease Biosimilars: Abbott has announced an expansion of its agreement with mAbxience Holdings S.L.

Biosimilars 57

Biosimilars 57

PharmaTech

APRIL 11, 2023

For studies involving products such as biologics and biosimilars, maintaining reliability of clinical supply can be challenging. Explore how different cold chain strategies can be leveraged to maintain product integrity in transit and minimize disruptions to clinical supply.

Biosimilars 40

Biosimilars 40

Pharma Packaging Solutions

SEPTEMBER 22, 2023

For example, what is the difference between biologics and biosimilars? What are Biosimilars? A biosimilar is a biologic that is similar enough to an existing FDA-approved product that it performs in exactly the same way, but different enough to avoid legal battles with the producers of the original product. Let’s talk about it.

Biosimilars 52

Biosimilars Packaging Vaccines 52

Big Molecule Watch

AUGUST 24, 2023

In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series , which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law. The post Biosimilars Webinar Series appeared first on Big Molecule Watch.

Biosimilars 52

Biosimilars Labelling 52

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

Labelling 62

Labelling Biosimilars Adverse Reactions Dosage 62

Big Molecule Watch

APRIL 5, 2023

On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA. The post Celltrion Announces Phase III Results for Aflibercept Biosimilar appeared first on Big Molecule Watch. and Europe later this year.

Biosimilars 57

Biosimilars Diabetes 57

Express Pharma

SEPTEMBER 4, 2023

Samsung Bioepis and Organon recently announced positive topline results from a Phase IV clinical trial of SB5, a biosimilar to the reference tumor necrosis factor (TNF) blocker Humira (adalimumab), in patients with moderate-to-severe chronic plaque psoriasis (PsO).

Biosimilars 52

Biosimilars 52

Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Celltrion and currently in Phase I for Osteoporosis.

Biosimilars 40

Biosimilars 40

Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Post Menopausal Osteoporosis.

Biosimilars 40

Biosimilars 40

Pharma in Brief

JANUARY 11, 2023

On December 20, 2022, the government of Ontario announced a new policy to expand the use of biosimilar drugs in the province. Patients receiving coverage under the Ontario Drug Benefit ( ODB ) program for eight originator biologic drugs will be required to transition to the biosimilar version by December 29, 2023. .

Biosimilars 52

Biosimilars 52

Pharmacy Times

JANUARY 15, 2024

Biosimilars are proven to be highly similar to the original products with no clinical meaningful differences.

Biosimilars 58

Biosimilars 58

Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Bone Metastasis.

Biosimilars 40

Biosimilars 40

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024.

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

Pharmaceutical Technology

MARCH 18, 2024

Adalimumab biosimilar is under clinical development by Biocon and currently in Phase III for Plaque Psoriasis (Psoriasis Vulgaris).

Biosimilars 40

Biosimilars 40

Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Humoral Hypercalcemia of Malignancy.

Biosimilars 40

Biosimilars 40

PharmaTech

MAY 31, 2023

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

Biosimilars 52

Biosimilars Packaging 52

Pharmaceutical Technology

FEBRUARY 15, 2023

JSR Life Sciences’ business unit Similis Bio is planning to collaborate with Novel351k for the development of three biosimilar programmes targeting cancer and autoimmune diseases. This will lead to pharmacokinetics/pharmacodynamic clinical trials.

Biosimilars 59

Biosimilars 59

pharmaphorum

JULY 29, 2021

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus. Biosimilars marketed in the US typically have list prices 15% to 35% lower than their reference products at launch.

Biosimilars 98

Biosimilars Diabetes 98

Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Giant Cell Tumor Of Bone.

Biosimilars 40

Biosimilars 40

Pharmaceutical Technology

FEBRUARY 21, 2024

Denosumab biosimilar is under clinical development by Lupin and currently in Phase III for Post Menopausal Osteoporosis.

Biosimilars 40

Biosimilars 40

Pharmaceutical Technology

FEBRUARY 8, 2024

Prabotulinumtoxin A biosimilar is under clinical development by AEON Biopharma and currently in Phase II for Migraine.

Biosimilars 40

Biosimilars 40

Pharmaceutical Technology

FEBRUARY 8, 2024

Prabotulinumtoxin A biosimilar is under clinical development by AEON Biopharma and currently in Phase II for Spasmodic Torticollis (Cervical Dystonia).

Biosimilars 40

Biosimilars 40

Pharmacy Times

OCTOBER 19, 2023

The FDA is the only authority that can designate a biosimilar as interchangeable with its reference product, which requires that the product has similar clinical results for the same indication.

Biosimilars 49

Biosimilars 49

Pharmaceutical Technology

JUNE 7, 2023

Rituximab biosimilar is under clinical development by Celltrion and currently in Phase II for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma).

Biosimilars 52

Biosimilars 52

pharmaphorum

SEPTEMBER 20, 2022

Novartis’ soon-to-be-divested Sandoz unit has positive clinical trial data in hand for a biosimilar of Amgen’s blockbuster osteoporosis therapy Prolia (denosumab), clearing the way for regulatory filings. Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and AryoGen Pharmed.

Biosimilars 52

Biosimilars 52