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.

Biosimilars 52

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

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

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.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

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

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

Biosimilars 52

Biosimilars Chemotherapy 52

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

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

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

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

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.

Biosimilars 52

Biosimilars Diabetes Chemotherapy Vaccines 52

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. It is the only drug in its class of chemotherapy and is developed from the natural substance found in a sea sponge. As of now, there are no the US FDA approved biosimilars available for Actemra.

Biosimilars 49

Biosimilars Diabetes Chemotherapy Immunity 49

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.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Immunity Immunization Biosimilars 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

chemotherapy-induced), pain, and post-traumatic stress disorder. chemotherapy-induced), and pain. chemotherapy-induced), and pain. FDA analyzed the following indications: anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, nausea and vomiting (e.g., at 63-64.

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

Pharmaceutical Technology

JULY 23, 2008

” Looming biosimilar legislation and the disregard for patents in the developing world is also threatening the intellectual property, and therefore profit margins, of companies looking to develop cancer drugs. “Intellectual property is becoming more of an issue,” says Ando.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Compounding Biosimilars 40

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

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

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

FDA Law Blog: Biosimilars

MAY 21, 2024

FDA analyzed anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, chemotherapy-induced nausea and vomiting, pain, and post-traumatic stress disorder. chemotherapy-induced), and pain for which there is a widespread current experience in the U.S. chemotherapy-induced), and pain. Basis at 64.

Controlled Substances 69

Controlled Substances Chemotherapy Dosage Labelling 69

European Pharmaceutical Review

APRIL 3, 2023

The committee recommended granting a paediatric-use marketing authorisation (PUMA) for Pedmarqsi (sodium thiosulfate) for preventing ototoxicity induced by cisplatin chemotherapy. Cisplatin is a chemotherapy used to treat several types of cancer. Ototoxicity is the development of hearing or balance problems due to a medicine.

Vaccines 98

Vaccines Chemotherapy Generic Medicine Biosimilars 98

RX Note

FEBRUARY 23, 2023

. - Drug registration number Medicines (Advertisement & Sale) Act 1956 and Regulations - To learn prohibitions of medicine advertisement and Medicine Advertisement Board Registration of Pharmacists Act 1951 and Regulations - Pharmacy Board Malaysia and legislation aspects of provisional, full and temporary registration Code of Ethics for Pharmacists (..)

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

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

Biosimilars 98

Biosimilars Chemotherapy 98

Big Molecule Watch

FEBRUARY 6, 2025

Henlius) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentechs PERJETA. This marks the first U.S.BLAacceptance for a pertuzumab biosimilar, a targeted therapy for select patients with HER2-positive breast cancer. On February 2, 2025, Shanghai Henlius Biotech, Inc.

Biosimilars 59

Biosimilars Chemotherapy 59

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.,

Biosimilars 130

Biosimilars Chemotherapy Packaging 130

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

European Pharmaceutical Review

FEBRUARY 3, 2025

Biosimilars given a positive opinion Dyrupeg (pegfilgrastim) to reduce the duration of neutropenia and help prevent febrile neutropenia following chemotherapy. Pavblu (aflibercept) and Skojoy (aflibercept) for the treatment of neovascular age-related macular degeneration and visual impairment related to various conditions.

Vaccines 52

Vaccines Generic Medicine Chemotherapy Biosimilars 52

FDA Law Blog: Biosimilars

MAY 5, 2024

FDA analyzed anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, nausea and chemotherapy-induced vomiting, pain, and post-traumatic stress disorder. at 63-64.

Controlled Substances 95

Controlled Substances Chemotherapy Dosage Labelling 95

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Today, experts generally agree that marijuana has currently accepted medical uses for several indications, including managing pain, spasms, and nausea in patients undergoing chemotherapy and stimulating appetite in patients with weight loss from AIDS.

Controlled Substances 59

Controlled Substances Chemotherapy Compounding 59