Big Molecule Watch

AUGUST 6, 2024

Midas Pharma GmbH’s Ranibizumab Midas for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularization.

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Big Molecule Watch

JULY 9, 2024

announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is the third biosimilar referencing STELARA to be approved by the FDA, following Amgen’s WEZLANA (ustekinumab-auub), approved in October 2023, and Alvotech’s and Teva’s SELARSDI (ustekinumab-aekn), approved in April 2024.

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Biosimilars Diabetes 49

Express Pharma

JULY 3, 2023

As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology. By the end of 2022, Indian pharma turned from volume to value creator.

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Biosimilars Drug Development Generic Medicine Diabetes 95

Express Pharma

MAY 22, 2024

Food and Drug Administration (US FDA) has approved the company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. ” Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics said, “Biosimilars are crucial for making healthcare more affordable and accessible.”

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Big Molecule Watch

DECEMBER 14, 2023

announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. Bio-Thera previously received approval for its TOFIDENCE (tocilizumab-bavi) biosimilar in September 2023. The post Recent Biosimilar Approvals appeared first on Big Molecule Watch.

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Biosimilars Diabetes 45

PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Additonally, Rezvoglar was also approved in the US on Nov 2022 In addition to Rezvoglar, Lilly is the owner of Humulin (recombinant human insulin), Humalog (reference insulin lispro), as well as an unbranded insulin lispro product 2.

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Big Molecule Watch

FEBRUARY 6, 2024

biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. CIMERLI was approved by the FDA on August 2, 2022 , and Coherus launched the product in the United States in October 2022. CIMERLI was approved by the FDA on August 2, 2022 , and Coherus launched the product in the United States in October 2022.

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Biosimilars Diabetes 69

PharmaShots

FEBRUARY 1, 2023

Ximluci is expected to be available in the UK in 2023 The approval for Ximluci was granted through the EC decision reliance procedure, whereby the MHRA’s decision was based on the EC Ximluci was approved in the UK for wet AMD, DME, diabetic retinopathy, RVO, and visual impairment due to choroidal neovascularization in adults.

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PharmaShots

APRIL 10, 2023

Shots: With an incurable nature and hefty medication costs, diabetes mellitus remains a global health concern and the seventh leading cause of death across the world. Diabetes, aka diabetes mellitus is a condition that arises when the pancreas fails to produce enough insulin or the cells of the body do not respond to the insulin produced.

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Diabetes Biosimilars Pharmaceutical Companies Pharmaceutical Companies 40

Pharmaceutical Technology

DECEMBER 22, 2022

Below you can find all the winners from the 2022 Excellence Awards which celebrate the greatest achievements and innovations in the industry. However in 2022 it achieved two further groundbreaking approvals for recurrent or metastatic HER2-low breast cancer, and previously treated, HER2-mutant non-small cell lung cancer (NSCLC).

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Diabetes Biosimilars Pharmaceutical Companies Pharmaceutical Companies 52

PharmaShots

JUNE 27, 2023

How was the ACR’22 experience for biosimilars for Biogen? We saw Biogen presented multiple results for different biosimilar molecules. Smriti: Can we talk about BIIB800, a tocilizumab biosimilar? The results up to Week 24 (Treatment Period 1) were previously reported at the EULAR European Congress of Rheumatology in 2022.

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Biosimilars Diabetes Immunity Immunization 40

PharmaShots

JUNE 7, 2023

Our team at PharmaShots has summarized 16 key events of the biosimilar space of May 2023 1. Sandoz Reports Real World Study Results of GP2013 (biosimilar, rituximab) for the Treatment of Rheumatoid Arthritis Date- May 08, 2023 Product: GP2013 (biosimilar, rituximab) The study incl. 84% vs 64%) & 2yr. (60%

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Biosimilars Packaging Diabetes Pharmaceutical Companies 40

European Pharmaceutical Review

AUGUST 21, 2023

According to Eli Lilly in early August 2023, its new products (select products launched since 2022: Jaypirca, Mounjaro and Omvoh) contributed $1.00 Its diabetes treatment Mounjaro led this outcome. This is mainly due to the reported decline in sales of Humira, a consequence of biosimilar competition. billion in Q2 2023.

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Biosimilars Diabetes Vaccines 98

Quality Matters

APRIL 4, 2023

USP standards build trust in biologics and biosimilars The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health. By 2022, that time was nearly cut in half, at nine to 12 months, and even shorter development timelines are expected in the next few years.

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Biosimilars Vaccines Drug Development Diabetes 52

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. Diabetes Therapy. 2022 [cited 2023Feb].

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Biosimilars Diabetes Immunity Immunization 105

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. However, non-NME and biosimilar approvals increased in 2022. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. months longer on the treatment.

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Biosimilars Diabetes Chemotherapy Vaccines 52

Express Pharma

APRIL 18, 2023

Sanofi (India) has recently received marketing approval from the Central Drugs Standard Control Organization (CDSCO) for soliqua (insulin glargine and lixisenatide recombinant fixed-dose combination) as an adjunct to diet and exercise in adults with obesity and type 2 diabetes (T2D), who are insufficiently controlled on oral or injectable therapies.

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Biosimilars Diabetes 52

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. Company: Supernus Pharmaceuticals Generic Name: Topiramate First Approval Date: Aug 16, 2013 Patent Expiration: Jan 2023 2022 Sales: $261.2M Banzel works for around ten different types of seizures by reducing their frequency and severity.

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Biosimilars Diabetes Chemotherapy Immunity 49

Pharmaceutical Technology

DECEMBER 20, 2022

trillion in Q2 2022 to $3.14 Eli Lilly saw strong global drug sales of $187m in Q3 for Mounjaro (tirzepatide), its new type 2 diabetes therapy, which was approved by the FDA in May 2022, according to GlobalData’s Drugs Database Pharma Intelligence Center. and 10%, respectively.

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Vaccines Diabetes Drug Pricing Biosimilars 52

Pharma in Brief

FEBRUARY 2, 2022

The feedback will inform a stakeholder session in spring 2022 and the Panel’s final report. The Panel focused on three therapeutic areas (cardiovascular disease, diabetes, psychiatric illnesses), which were chosen for their high rate of prescription drug use, among other reasons. Drug cost was not a consideration.

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Insurance Coverage and Processing Biosimilars Diabetes 59

Pharmaceutical Technology

JANUARY 10, 2023

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

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pharmaphorum

OCTOBER 18, 2022

billion) this time last year to CHF 600 million, while therapeutics Ronapreve (casirivimab/imdevimab) and Actemra/RoActemra (tocilizumab) shrank around CHF 1 billion “as the pandemic continued to weaken in many countries in 2022,” said the company in its quarterly update (PDF). billion of its total pharma sales of CHF 33.19

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Biosimilars Diabetes 52

PharmaShots

APRIL 13, 2023

The company faced a tough time in 2019 as the first biosimilars for its best-selling drugs (Rituxan, Avastin, and Herceptin) emerged. from 2018 to 2019 Roche’s blockbuster drugs, Herceptin, Avastin, and Rituxan played significantly well against its biosimilar products. Moreover, its medical device sales faced a decline of 1.7%

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Pharmaceutical Technology

FEBRUARY 18, 2023

The company offers generic medicines and biosimilars through Sandoz. The company reported revenues of (US Dollars) US$51,742 million for the fiscal year ended December 2022 (FY2022), a decrease of 2.1% Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). over FY2021.

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Diabetes Generic Medicine Biosimilars Immunity 40

PharmaShots

APRIL 3, 2023

at current exchange rates In Oct 2022, the acquisition was initiated and the transaction is expected to be adjusted per share by $0.07 Date - Jan 04, 2023 Product – N/A The acquisition is completed from a shareholder group led by Nordic Capital, in an all-cash transaction valued at $2.8B events/100 patient-yrs.) The authorization incl.

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Biosimilars Diabetes Compounding Hospitals 40

PharmaShots

FEBRUARY 27, 2023

Addepalli Veeranjaneyulu and Shubhadeep Debabrata Sinha introduced the session by describing the function of PV in the safety profiles of biosimilars. To provide the audience with an Indian viewpoint, the presenters pointed out the country's requirements for biosimilar PV. Dr. Mangesh.

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Biosimilars Diabetes Packaging Hospitals 40

Putting Patients First Blog

JANUARY 27, 2025

The NHC recognizes that Medicare already covers AOMs for patients who are overweight and have comorbid conditions such as diabetes or cardiovascular disease. To further strengthen these efforts, the NHC recommends that CMS adopt additional measures to ensure broad access to generics, biosimilars, and other cost-effective treatments.

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European Pharmaceutical Review

FEBRUARY 17, 2023

The European Medicines Agency (EMA) has released a report detailing its Human Medicines Highlights 2022. The document contains an overview of the agency’s key recommendations in 2022. Human medicines highlights 2022 – additional details Public health emergencies remained a key priority for the European Medicines Agency in 2022.

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pharmaphorum

MARCH 3, 2022

Non-profit drugmaker Civica Rx has said it will launch biosimilars of three big-selling insulin products in the US by 2024 to help diabetic patients struggling with the cost of the drugs. Cheaper options are meanwhile becoming available.

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Biosimilars Diabetes Mayo Clinic 52

pharmaphorum

MARCH 23, 2022

The US Senate will vote in the coming weeks on whether to introduce a $35 cap on the monthly cost of insulin to patients that was endorsed by President Joe Biden in his 2022 State of the Union address. Expressing his support for the bill last month, he claimed that one in four Americans are being forced to ration insulin doses due to cost.

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Diabetes Biosimilars Drug Pricing 75

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 (..)

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

Safe Biologics

APRIL 10, 2023

CMS Releases Guidance Memo on Medicare Drug Price Negotiation; Allows Only 30 Days to Comment On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare Drug Price Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022.

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Express Pharma

JANUARY 3, 2025

One of the trends set to define 2025, and the decade ahead, is the 2022-30 patent cliff, and the gradual shift in biopharma revenues from small to large molecules. While India was able to leverage the 2008 patent cliff of small molecules, the same playbook will not work for biologics and biosimilars. per cent by 2026 and 37.5

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