Pharma Rep Focus

Innovative Strategies to Maintain Product Integrity in Biologic and Biosimilar Clinical Studies

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.

Patent expiration to drive biosimilars market expansion to 2032

European Pharmaceutical Review

APRIL 11, 2024

Over the past few years, the biosimilar market has expanded “rapidly” due to these medicines offering a cost-effective alternative to the reference product. As of September 2022, there were around 39 biosimilars approved and 22 marketed, the report stated. million by 2032, at 17.6 percent CAGR between 2023 and 2032.

Marketing

Marketing Competition Manufacturing Healthcare Provider

First European ustekinumab biosimilar to Stelara approved

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.

Competition

Competition Marketing Safety Manufacturing

European Commission authorises one of first ustekinumab biosimilars in Europe

European Pharmaceutical Review

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

Food and Drug Administration

Food and Drug Administration Medicine Marketing Food

Sandoz granted novel biosimilars approval

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines.

Food and Drug Administration

Food and Drug Administration Medicine FDA Food

Biosimilars Gain Traction in Oncology but Nuances Incorporating Them Discussed at ACCC 49th Annual Meeting & Cancer Center Business Summit

PM360

JULY 26, 2023

As biosimilars make inroads across various disease states, oncology especially appears to have embraced the new breed of therapies. Biosimilar adoption, however, is not as simple as picking the lowest-cost option, according to one expert. The study examined the use of six biosimilars across 38 practices between 2019 and 2021.

Manufacturing

Manufacturing Patients Marketing Insurance

FDA approves first Stelara biosimilar, Wezlana

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

Food and Drug Administration

Food and Drug Administration FDA Side effects Safety

The Future of Biosimilars Marketing

PM360

AUGUST 24, 2023

biosimilars market is evolving rapidly and pharma marketing programs need to evolve as well to better meet physician needs. The increased use of biosimilars has the potential to result in significant cost savings for the U.S. But how can biosimilar brands most effectively support providers and patients throughout the care journey?

Marketing

Marketing Physicians Electronics Side effects

Samsung Bioepis Initiates Phase 3 Clinical Trial for Proposed Pembrolizumab Biosimilar

Pharmacy Times

APRIL 22, 2024

The trial will compared the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and pembrolizumab for metastatic non-squamous non-small cell lung cancer.

Safety

Sandoz to file for approval of aflibercept biosimilar

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®.

Safety

Safety Pharmaceutical Patients Marketing

Sandoz to commercialise mAb biosimilar candidate

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.,

Biopharma

Biopharma Manufacturing Medicine Safety

Clinical Results Support Greater Use of Oncology Biosimilars

Pharmacy Times

OCTOBER 14, 2022

Presenters at the AMCP Nexus conference explore outcomes data and whether these medications should be substituted for reference products more frequently.

Medical

Eculizumab biosimilar gets positive CHMP opinion

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.

Medicine

Medicine Patients Pharmaceutical Marketing

2022 WHO Biosimilar Guideline improves access, IGBA says

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.

Medicine

Medicine Safety Healthcare Healthcare

Biosimilar Drugs Found as Clinically Effective as Reference Drugs, More Affordable

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 Market Set for Biggest Year Yet in 2023

PM360

APRIL 25, 2023

biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays. Growing Comfort Levels Among Providers Biosimilar utilization has had steady growth in the U.S. In perhaps the most significant moment for the U.S.

Marketing

Marketing Competition Government Manufacturing

EMA approves biosimilar interchangeability in EU

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.

Medicine

Medicine Side effects Safety Doctors

Denosumab biosimilar by Sandoz Group for Humoral Hypercalcemia of Malignancy: Likelihood of Approval

Pharmaceutical Technology

MARCH 18, 2024

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

Denosumab biosimilar by Sandoz Group for Post Menopausal Osteoporosis: Likelihood of Approval

Pharmaceutical Technology

MARCH 18, 2024

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

Adalimumab biosimilar by Biocon for Plaque Psoriasis (Psoriasis Vulgaris): Likelihood of Approval

Pharmaceutical Technology

MARCH 18, 2024

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

Denosumab biosimilar by Sandoz Group for Giant Cell Tumor Of Bone: Likelihood of Approval

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.

Denosumab biosimilar by Sandoz Group for Bone Metastasis: Likelihood of Approval

Pharmaceutical Technology

MARCH 18, 2024

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

Consequences of the First 10 Drugs Selected for Medicare’s Negotiation Program

PM360

SEPTEMBER 21, 2023

They do not have biosimilar or generic competition available in the market. Over the next few weeks, manufacturers will submit a range of clinical, marketing, sales, pricing, and patient data, and then meet with CMS to discuss submissions later this fall. They do not qualify for any exemption (e.g.,

Manufacturing

Manufacturing Competition Marketing Physicians

Denosumab biosimilar by Celltrion for Osteoporosis: Likelihood of Approval

Pharmaceutical Technology

MARCH 18, 2024

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

Similis Bio plans to partner with Novel351k for biosimilars development

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.

Manufacturing

Manufacturing Medicine Leads Patients

Biosimilars Provide New Treatment Opportunities For Wide Range of Conditions

Pharmacy Times

JANUARY 15, 2024

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

Ranibizumab biosimilar by Generium for Wet (Neovascular / Exudative) Macular Degeneration: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 23, 2023

Ranibizumab biosimilar is under clinical development by Generium and currently in Phase III for Wet (Neovascular / Exudative) Macular Degeneration. GlobalData’s report assesses how Ranibizumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Pharmaceutical

Prabotulinumtoxin A biosimilar by AEON Biopharma for Spasmodic Torticollis (Cervical Dystonia): Likelihood of Approval

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).

Biopharma

Trastuzumab biosimilar by Qilu Pharmaceutical for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer): Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 7, 2024

Trastuzumab biosimilar is under clinical development by Qilu Pharmaceutical and currently in Phase III for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer).

Pharmaceutical

Denosumab biosimilar by Lupin for Post Menopausal Osteoporosis: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 21, 2024

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

Pharma’s reputational high will be short-lived

World of DTC Marketing

MARCH 17, 2021

A great example of pharma’s profiteering is biosimilar drugs which cost a lot and add billions of dollars to healthcare costs. million, the company disclosed in a proxy filing” No biosimilar will take on Humira’s $16 billion in 2020 U.S. They need to be extensively tested in long and expensive clinical trials.

Pharma

Pharma Competition Prescription Doctors

The Evolution of Biosimilars from Their Beginning Until Now—And What’s Next

PM360

SEPTEMBER 28, 2022

Chrys Kokino has been involved in the biosimilars market prior to the first biosimilar being approved in Europe in 2006. he is responsible for leading the commercialization efforts of specialty products which includes a broad portfolio of biosimilars. In a previous life, I was heading up one of their anti-biosimilar task forces.

Competition

Competition Marketing Biopharma Manufacturing

Celltrion’s Yuflyma receives US FDA approval for multiple conditions

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

Food and Drug Administration

Food and Drug Administration FDA Food Safety

Rituximab biosimilar by Celltrion for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma): Likelihood of Approval

Pharmaceutical Technology

JUNE 7, 2023

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

Prabotulinumtoxin A biosimilar by AEON Biopharma for Migraine: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 8, 2024

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

Biopharma

Palivizumab biosimilar by Mabxience Holding for Respiratory Syncytial Virus (RSV) Infections: Likelihood of Approval

Pharmaceutical Technology

JANUARY 4, 2024

Palivizumab biosimilar is under clinical development by Mabxience Holding and currently in Phase I for Respiratory Syncytial Virus (RSV) Infections.

EMA Accepts MAAs from Sandoz for Proposed Denosumab Biosimilar

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.

Marketing

Tocilizumab biosimilar by Fresenius Kabi SwissBioSim for Systemic-Onset Juvenile Idiopathic Arthritis (Still Disease): Likelihood of Approval

Pharmaceutical Technology

DECEMBER 20, 2023

Tocilizumab biosimilar is under clinical development by Fresenius Kabi SwissBioSim and currently in Pre-Registration for Systemic-Onset Juvenile Idiopathic Arthritis (Still Disease).

Clinical Overview: Cyletzo, a Biosimilar Version of Adalimumab

Pharmacy Times

JULY 19, 2022

Indications for adalimumab include ankylosing spondylitis, Crohn disease, chronic plaque psoriasis, juvenile idiopathic arthritis, moderate to severe rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

Interchangeability Designation Still Widely Debated, Prescribers Hesitant About Biosimilars

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.

FDA

Tocilizumab biosimilar by Fresenius Kabi SwissBioSim for Rheumatoid Arthritis: Likelihood of Approval

Pharmaceutical Technology

OCTOBER 26, 2023

Tocilizumab biosimilar is under clinical development by Fresenius Kabi SwissBioSim and currently in Pre-Registration for Rheumatoid Arthritis.

Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

DECEMBER 19, 2022

A biosimilar is a biological medicine ‘similar’ to another biological medicine already approved in the EU (the ‘reference medicine’). 1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product.

Medicine

Medicine Biopharma Safety Food

Tocilizumab biosimilar by Bio-Thera Solutions for Rheumatoid Arthritis: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 22, 2023

Tocilizumab biosimilar is under clinical development by Bio-Thera Solutions and currently in Pre-Registration for Rheumatoid Arthritis.

FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity

Pharmaceutical Technology

AUGUST 5, 2022

Cimerli is a biosimilar of Lucentis (ranibizumab) and has been granted 12 months of interchangeability exclusivity across five different retinal diseases: DME, diabetic retinopathy (DR), neovascular (wet) age-related macular degeneration (AMD), myopic choroidal neovascularisation (mCNV), and macular oedema following retinal vein occlusion (RVO).

Food and Drug Administration

Food and Drug Administration FDA Safety Insurance

Innovative Strategies to Maintain Product Integrity in Biologic and Biosimilar Clinical Studies

Patent expiration to drive biosimilars market expansion to 2032

Trending Sources

First European ustekinumab biosimilar to Stelara approved

European Commission authorises one of first ustekinumab biosimilars in Europe

Sandoz granted novel biosimilars approval

Biosimilars Gain Traction in Oncology but Nuances Incorporating Them Discussed at ACCC 49th Annual Meeting & Cancer Center Business Summit

FDA approves first Stelara biosimilar, Wezlana

The Future of Biosimilars Marketing

Samsung Bioepis Initiates Phase 3 Clinical Trial for Proposed Pembrolizumab Biosimilar

Sandoz to file for approval of aflibercept biosimilar

Sandoz to commercialise mAb biosimilar candidate

Clinical Results Support Greater Use of Oncology Biosimilars

Eculizumab biosimilar gets positive CHMP opinion

2022 WHO Biosimilar Guideline improves access, IGBA says

Biosimilar Drugs Found as Clinically Effective as Reference Drugs, More Affordable

Biosimilars Market Set for Biggest Year Yet in 2023

EMA approves biosimilar interchangeability in EU

Denosumab biosimilar by Sandoz Group for Humoral Hypercalcemia of Malignancy: Likelihood of Approval

Denosumab biosimilar by Sandoz Group for Post Menopausal Osteoporosis: Likelihood of Approval

Adalimumab biosimilar by Biocon for Plaque Psoriasis (Psoriasis Vulgaris): Likelihood of Approval

Denosumab biosimilar by Sandoz Group for Giant Cell Tumor Of Bone: Likelihood of Approval

Denosumab biosimilar by Sandoz Group for Bone Metastasis: Likelihood of Approval

Consequences of the First 10 Drugs Selected for Medicare’s Negotiation Program

Denosumab biosimilar by Celltrion for Osteoporosis: Likelihood of Approval

Similis Bio plans to partner with Novel351k for biosimilars development

Biosimilars Provide New Treatment Opportunities For Wide Range of Conditions

Ranibizumab biosimilar by Generium for Wet (Neovascular / Exudative) Macular Degeneration: Likelihood of Approval

Prabotulinumtoxin A biosimilar by AEON Biopharma for Spasmodic Torticollis (Cervical Dystonia): Likelihood of Approval

Trastuzumab biosimilar by Qilu Pharmaceutical for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer): Likelihood of Approval

Denosumab biosimilar by Lupin for Post Menopausal Osteoporosis: Likelihood of Approval

Pharma’s reputational high will be short-lived

The Evolution of Biosimilars from Their Beginning Until Now—And What’s Next

Celltrion’s Yuflyma receives US FDA approval for multiple conditions

Rituximab biosimilar by Celltrion for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma): Likelihood of Approval

Prabotulinumtoxin A biosimilar by AEON Biopharma for Migraine: Likelihood of Approval

Palivizumab biosimilar by Mabxience Holding for Respiratory Syncytial Virus (RSV) Infections: Likelihood of Approval

EMA Accepts MAAs from Sandoz for Proposed Denosumab Biosimilar

Tocilizumab biosimilar by Fresenius Kabi SwissBioSim for Systemic-Onset Juvenile Idiopathic Arthritis (Still Disease): Likelihood of Approval

Clinical Overview: Cyletzo, a Biosimilar Version of Adalimumab

Interchangeability Designation Still Widely Debated, Prescribers Hesitant About Biosimilars

Tocilizumab biosimilar by Fresenius Kabi SwissBioSim for Rheumatoid Arthritis: Likelihood of Approval

Interchangeability of biosimilars in the EU – the industry impact

Tocilizumab biosimilar by Bio-Thera Solutions for Rheumatoid Arthritis: Likelihood of Approval

FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity

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