pharmaphorum

NOVEMBER 16, 2020

The EMA’s human medicines committee has recommended approval of a fixed-dose combination of Roche’s breast cancer drugs Herceptin and Perjeta – part of the company’s defense against Herceptin biosimilars. billion in the same period as biosimilars ate into its market share. billion ($3.2

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Pharmaceutical Business Review

JULY 10, 2024

It is to be used in combination with other antiemetic agents to prevent both acute and delayed nausea and vomiting following highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, as well as with moderately emetogenic cancer chemotherapy (MEC).

Chemotherapy 59

Chemotherapy Biosimilars Hospitals 59

Big Molecule Watch

MARCH 13, 2023

On March 6, 2023, Coherus Biosciences announced FDA approval of an autoinjectable version of Udenyca, Coherus’ biosimilar to Amgen’s Neulasta (pegfilgrastim). Udenyca (pegfilgrastim-cbqv) was first launched in the US in January 2019 and is one of six FDA approved pegfilgrastim biosimilars.

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Biosimilars Chemotherapy 52

pharmaphorum

AUGUST 2, 2022

The trial involved cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who were getting treatment with Tecentriq second-line after earlier platinum-based chemotherapy failed.

Chemotherapy 105

Chemotherapy Biosimilars 105

Big Molecule Watch

JANUARY 10, 2025

As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone. Here are some of the top regulatory developments from 2024.

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Biosimilars Drug Pricing Labelling Communication 45

pharmaphorum

DECEMBER 23, 2020

Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer to patients – and also provides a defence against biosimilar competition. That’s a drop in the ocean compared to the CHF 1.5

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pharmaphorum

OCTOBER 19, 2021

Innovent has only released top-line data from the 480-subject ORIENT-31 study so far, but said sintilimab given with its bevacizumab biosimilar Byvasda on top of chemotherapy with Lilly’s own Alimta (pemetrexed) and cisplatin had a statistically significant improvement in PFS.

Chemotherapy 52

Chemotherapy Biosimilars Hospitals 52

Pharmacy Times

FEBRUARY 9, 2024

Bevacizumab is a recombinant humanized G1 monoclonal anti-vascular endothelial growth factor antibody that is used in combination with chemotherapy to treat solid tumors.

Chemotherapy 26

Chemotherapy Biosimilars 26

pharmaphorum

SEPTEMBER 29, 2020

China’s Junshi Biosciences has said it plans filings for a new cancer immunotherapy after its toripalimab outperformed standard chemotherapy in cancer of the upper throat in a phase 3 trial. Toripalimab is a PD-1 inhibitor that is already approved for treatment of metastatic melanoma in China.

Chemotherapy 40

Chemotherapy Biosimilars 40

pharmaphorum

OCTOBER 10, 2022

The study showed that the combination has the potential to “provide a safer and better tolerated alternative” to the use of PD-1/PD-L1 drugs plus chemotherapy in first-line NSCLC, the current standard of treatment, according to Dr Chris Redhead of Goetz Partners. month mPFS with Keytruda plus chemo, with fewer side effects.

Chemotherapy 59

Chemotherapy Biosimilars 59

pharmaphorum

OCTOBER 3, 2022

This typically sees higher-priced drugs, even in oncology, being sidelined in favour of biosimilars, off-patent branded drugs, or locally manufactured alternatives, unless manufacturers offer significant discounting to gain access to national essential medicines lists. Meeting of the Oncologic Drugs Advisory Committee. Dec 2021.

Chemotherapy 98

Chemotherapy Biosimilars Pharmaceutical Companies Pharmaceutical Companies 98

Quality Matters

FEBRUARY 6, 2025

Because of a monoclonal antibody's ability to recognize and connect to a cancer cell, it can serve as a delivery vehicle for other treatments, such as chemotherapy and radiation. This approach can reduce damage to healthy cells because the monoclonal antibody transports the treatment directly to the target cancer cells.

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HIV Treatment and Prevention Agents Immunity Immunization Biosimilars 52

PharmaShots

MAY 12, 2023

Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)

Chemotherapy 40

Chemotherapy Biosimilars Immunity Immunization 40

Express Pharma

DECEMBER 11, 2024

As a first-line treatment in combination with standard chemotherapy (gemcitabine and cisplatin), it demonstrates a remarkable 48 per cent reduction in disease progression or death risk compared to traditional therapies. The drug is also approved as a monotherapy for patients experiencing disease progression after platinum-based chemotherapy.

Biosimilars 105

Biosimilars Chemotherapy 105

Safe Biologics

AUGUST 23, 2024

as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S. In the U.S., In the U.S.,

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Biosimilars Chemotherapy Packaging 130

Pharmacy Times

JUNE 13, 2025

Vitamin D supplementation increased 25-hydroxyvitamin-D levels significantly, suggesting a potential role in enhancing chemotherapy effectiveness. The study's findings support further research with larger samples to explore vitamin D's impact on chemotherapy and breast cancer remission likelihood.

Chemotherapy 56

Chemotherapy Pharmacy Technician Immunity Immunization 56

Pharmacy Times

JUNE 12, 2025

The session, which was entitled “Decoding the Logic: An Overview of Biologics and Biosimilars,” described clinical applications and economic impacts associated with biologics and biosimilars over the last 10 to 15 years, as well as outlined what skills effectively contribute to their management and understanding.

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Biosimilars Pharmacy Technician Immunity Immunization 29

pharmaphorum

SEPTEMBER 8, 2020

In my role at Sandoz, I work with teams that are passionately trying to drive healthcare sustainability through the increased use of high-quality biosimilars. 7 With a typical price difference between reference biologics and biosimilars in the range of -15% to -80%, the immediate potential budget impacts are in the tens of billions.

Biosimilars 99

Biosimilars Drug Pricing Chemotherapy Vaccines 99

Pharmacy Times

JUNE 16, 2025

Transportation barriers, as a health-related social need, significantly impact FN rates in chemotherapy patients. Febrile neutropenia (FN) remains a serious and common complication of chemotherapy. A 67% FN rate difference between pegfilgrastim and filgrastim was observed in patients with transportation barriers.

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Inpatient HIV Treatment and Prevention Agents Pharmacy Technician Chemotherapy 26

Pharmacy Times

JUNE 19, 2025

1 Biomarker testing is relatively new in the treatment landscape for NSCLC but has proven incredibly important for personalizing patient care, transforming from a generic chemotherapy approach to a highly personalized, genomically driven treatment strategy. For advanced disease, chemotherapy was the standard.

Chemotherapy 26

Chemotherapy Pharmacy Technician Compounding Pharmacies Hospitals 26

pharmaphorum

NOVEMBER 3, 2021

HER2-positive gastric cancer is generally treated first with chemotherapy plus Roche’s Herceptin (trastuzumab) or a biosimilar in Europe, but treatment options are few if the disease progresses, according to Daiichi Sankyo’s head of oncology R&D Gilles Gallant. billion licensing deal.

Chemotherapy 98

Chemotherapy Biosimilars Labelling 98

European Pharmaceutical Review

APRIL 30, 2024

If approved, fruquintinib could provide a new oral, chemotherapy-free option as the first and only selective inhibitor of all three vascular endothelial growth factor receptors (VEGFR) receptors approved in the EU for this disease, according to Takeda.

Biosimilars 98

Biosimilars Generic Medicine Chemotherapy Hospitals 98

pharmaphorum

AUGUST 9, 2021

Another phase 3 trial – called POLARGO – is comparing Polivy, Rituxan and chemotherapy with gemcitabine and oxaliplatin to the Rituxan/chemo regimen as a second-line therapy for DLBCL.

Chemotherapy 66

Chemotherapy Biosimilars 66

Pharmacy Times

JUNE 11, 2025

Approximately 40% to 80% of patients with cancer who are assigned female at birth face possible infertility as a result of their cancer treatments, such as chemotherapy, radiation, and surgery. An additional 15% to 30% of cancer survivors who are assigned male at birth also face infertility as a result of chemotherapy.

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Pharmacy Technician Specialty Pharmacies Biosimilars Compounding Pharmacies 29

pharmaphorum

DECEMBER 18, 2020

Margenza (margetuximab) won FDA approval in combination with chemotherapy to treat metastatic HER2-positive breast cancer after at least two previous rounds of therapy. The median progression-free survival (PFS) of patients treated with Margenza and chemotherapy was 5.8 months in patients treated with trastuzumab and chemotherapy.

Chemotherapy 52

Chemotherapy Biosimilars Immunity Immunization 52

Pharmacy Times

JUNE 10, 2025

Related Videos Related Content Advertisement June 10th 2025 Inpatient Biosimilar Use Grows, Offering Cost-Saving Opportunities for Health Systems Aislinn Antrim, Managing Editor June 3rd 2025 S2. December 21, 2004. Subscribe Now!

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Pharmacy Technician HIV Treatment and Prevention Agents Compounding Pharmacies Biosimilars 29

Pharmacy Times

JUNE 18, 2025

Mok : Right now, we have a lot of chemotherapy being used, but there are many more novel treatments being studied, especially in earlier lines of treatment. Bispecifics are moving up in the lymphoma space, and these newer therapies may have some synergistic effects with chemotherapy. REFERENCES 1. Updated August 18, 2021.

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Pharmacy Technician Chemotherapy Compounding Pharmacies Pharmacy Management 26

pharmaphorum

NOVEMBER 24, 2021

Back in August, Roche said that Polivy an antibody-drug conjugate targeting CD79b, achieved its main objective of extending PFS when added to treatment with Roche’s Rituxan/MabThera (rituximab) plus chemotherapy for DLBCL, an aggressive form of non-Hodgkin’s lymphoma.

Chemotherapy 59

Chemotherapy Biosimilars 59

Pharmacy Times

JUNE 11, 2025

Additionally, patients may have received prior chemotherapy for advanced disease. Additionally, taletrectinib was granted priority review, breakthrough designation, and orphan drug designation for this indication. For both trials, the major efficacy outcomes were confirmed overall response rate (cORR) and duration of response (DOR).

Pharmacy Technician 29

Pharmacy Technician Biosimilars Compounding Pharmacies Pharmacy Management 29

pharmaphorum

MARCH 28, 2022

The CHMP backed Polivy (polatuzumab vedotin) for previously-untreated diffuse large B-cell lymphoma (DLBCL) in combination with R-CHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone) late last week.

Chemotherapy 52

Chemotherapy Biosimilars 52

Pharmacy Times

JUNE 9, 2025

Related Videos Related Content Advertisement June 9th 2025 Neoadjuvant Nivolumab With Chemotherapy Yields Significant Overall Survival Benefit in Resectable NSCLC Luke Halpern, Assistant Editor June 3rd 2025 S2. N Engl J Med. 2019;380:2020-2030. Subscribe Now!

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Pharmacy Technician Compounding Pharmacies Hospitals Pharmacy Management 29

Pharmacy Times

JUNE 9, 2025

Related Videos Related Content Advertisement June 9th 2025 Neoadjuvant Nivolumab With Chemotherapy Yields Significant Overall Survival Benefit in Resectable NSCLC Luke Halpern, Assistant Editor June 3rd 2025 S2. Subscribe Now!

Pharmacy Technician 29

Pharmacy Technician Compounding Pharmacies Diabetes Hospitals 29

pharmaphorum

DECEMBER 21, 2022

Kadcyla is the standard HER2 therapy for breast cancer patients whose disease has progressed despite prior treatment with trastuzumab (Roche’s Herceptin or a biosimilar) plus taxane chemotherapy.

Chemotherapy 64

Chemotherapy Biosimilars 64

Pharmacy Times

JUNE 18, 2025

Martino, PharmD, BCOP, APh Kaitlyn Wells, PharmD Sam Martinez, PharmD, BCOP, BCPS Craig A. Martino, PharmD, BCOP, APh Kaitlyn Wells, PharmD Sam Martinez, PharmD, BCOP, BCPS Craig A.

Pharmacy Technician 26

Pharmacy Technician Diabetes Immunity Immunization 26

Pharmacy Times

JUNE 17, 2025

Conclusions We demonstrated the feasibility of leveraging a complex EHR data source from an integrated health system to study the impact of dose modifications on clinical outcomes for self-administered chemotherapy. Nearly half of the patients with CML on imatinib experienced dosage modifications in this study.

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Pharmaceutical Technology

JANUARY 30, 2023

However, non-NME and biosimilar approvals increased in 2022. In 2023, there will be opportunities for a wider range of CMOs that can offer services for less innovative drugs requiring reformulation or biosimilar production. There were 38 innovator and biosimilar orphan drug approvals for the US in 2022.

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Biosimilars Diabetes Chemotherapy Vaccines 52

Pharmacy Times

JUNE 20, 2025

For effective patient care, we need smart people to design workflows for operationalizing 505(b)(2) drugs, integrating the next biosimilar we have to stock, and managing the compounding of a new hazardous drug. We need people to coordinate and track prior authorizations, write persuasive appeal letters, and keep patients updated.

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