Biosimilars and Generic Medicine - Pharmacist Digest

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Biosimilars

Generic Medicine

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Next drug patent cliff to challenge Big Pharma strategy

European Pharmaceutical Review

JULY 4, 2025

Pharma companies will need to “rethink revenue strategies, pipeline investments, and lifecycle management to safeguard long-term growth”, as a greater number of biosimilars and generic medicines gain market entry, according to a recent report by the data and analytics company.

Generic Medicine

Generic Medicine Biosimilars

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CHMP meeting highlights – May 2025

European Pharmaceutical Review

MAY 27, 2025

Generic medicine Emtricitabine/Tenofovir alafenamide Viatris (emtricitabine / tenofovir alafenamide), received a positive opinion to treat adults and adolescents with human immunodeficiency virus type 1 (HIV-1). The CHMP will issue its final recommendations of the medicine in due course.

Biosimilars Generic Medicine

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STAT+: ‘Skinny labels’ on generic medicines saved Medicare $15 billion over a recent six-year period

STAT

APRIL 30, 2024

A controversial provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare Part D nearly $15 billion from 2015 to 2021 on just 15 medicines during that period, according to a new analysis.

Labelling Generic Medicine Biosimilars

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Sandoz to become standalone company

European Pharmaceutical Review

AUGUST 25, 2022

Novartis has announced that it intends to separate Sandoz , its generics and biosimilars division into a new publicly traded standalone company. The 100 percent spin-off aims to establish Sandoz as the premier European generics company and a global leader in biosimilars, maximising shareholder value.

Biosimilars Generic Medicine

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Inflation threatens supply of life-saving generics to Europe

Pharmaceutical Technology

DECEMBER 15, 2022

On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

Generic Medicine

Generic Medicine Drug Pricing Biosimilars Hospitals

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Sandoz bulks up ahead of possible sale with Coalesce buy

pharmaphorum

MARCH 14, 2022

For Sandoz, the acquisition gives it a technology platform in an area of the generic medicines market with a relatively high barrier to entry, as developing inhaled medicines poses “comparatively high technical complexity,” according to Sandoz chief executive Richard Saynor.

Generic Medicine

Generic Medicine Biosimilars

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Novartis announces plans to spin off Sandoz business

Pharmaceutical Technology

AUGUST 26, 2022

Novartis has announced plans to completely spin off its generics and biosimilars division, Sandoz, to create a new publicly traded standalone firm. The latest development is intended to increase shareholder value by establishing a top European generics firm and a leader in biosimilars internationally.

Biosimilars Generic Medicine

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Is India capable of ensuring equitable access to biopharmaceuticals?

Express Pharma

SEPTEMBER 6, 2023

In a bid to resolve both physical and financial restrictions inhibiting equitable access to quality medicines, the Jan Aushadhi scheme was launched in 2008 and envisaged the setting up of dedicated Janaushadhi Kendras to provide quality generic medicines at capped prices for the general public.

Insurance Coverage and Processing

Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing

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KFA-115 by Novartis for Melanoma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 28, 2023

The company offers generic medicines and biosimilars through Sandoz. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others.

Generic Medicine

Generic Medicine Biosimilars Immunization Immunity

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Sustained healthcare systems need sustainable pharma business models

pharmaphorum

OCTOBER 26, 2021

We certainly have a problem with national-level procurement policies that put almost no value on generic medicines … that approach needs to change. Access is dependent on securing a robust medicines supply chain, meaning companies need to invest in European manufacturing facilities.

Generic Medicine

Generic Medicine Biosimilars

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Teva poaches Vertex exec as new head of R&D

pharmaphorum

JULY 4, 2022

Hughes will take charge of an R&D unit spending around $1 billion on R&D across Teva’s generics, biosimilars and speciality medicines categories – two-thirds spent in the US – at 26 R&D sites worldwide, employing around 3,500 scientists.

Generic Medicine

Generic Medicine Biosimilars

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KFA-115 by Novartis for Malignant Mesothelioma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 28, 2023

The company offers generic medicines and biosimilars through Sandoz. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others.

Generic Medicine

Generic Medicine Biosimilars Immunization Immunity

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CHMP meeting highlights – July 2024

European Pharmaceutical Review

JULY 29, 2024

Subject to regulatory approval by the European Commission, Yuvanci ® would be the only single tablet combination therapy in Europe for pulmonary arterial hypertension, Johnson & Johnson Innovative Medicine shared. Tuznue (trastuzumab) for breast and gastric cancer.

Generic Medicine

Generic Medicine Biosimilars

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Iptacopan hydrochloride by Novartis for Paroxysmal Nocturnal Hemoglobinuria: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 28, 2023

The company offers generic medicines and biosimilars through Sandoz. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others.

Generic Medicine

Generic Medicine Immunity Immunization Biosimilars

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Iptacopan hydrochloride by Novartis for Glomerulonephritis: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 28, 2023

The company offers generic medicines and biosimilars through Sandoz. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others.

Generic Medicine

Generic Medicine Immunity Immunization Biosimilars

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Omnibus Spending Law: Provisions Will Bolster Medicines Supply Chain Insights and Advanced Manufacturing Technologies

Quality Matters

JANUARY 23, 2023

Leveraging insights from data on USP standards distribution and usage at more than 22,000 locations worldwide and 40+ external data sets, USP launched the Medicine Supply Map in 2021 to provide an early-warning capability for supply chain vulnerabilities. Such products include small molecule medicines, biologics and biosimilars.

Generic Medicine

Generic Medicine Pharmaceutical Manufacturing Biosimilars Communication

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PMPRB launches consultation on revised Draft Guidelines

Pharma in Brief

JUNE 21, 2020

Medicines with an annual treatment cost >150% of GDP/capita or maximum expected market size >$50 M will be classified as Category I, except biosimilars and generics. Medicines falling below these thresholds, as well as biosimilars and generics, will be classified as Category II.

Biosimilars Generic Medicine Dosage Documentation

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Risk adjusted net present value: What is the current valuation of Novartis’s Gevokizumab?

Pharmaceutical Technology

FEBRUARY 18, 2023

The company offers generic medicines and biosimilars through Sandoz. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others.

Diabetes Generic Medicine Biosimilars Immunization

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Waters, as a strategic partner to the pharma industry, can help India become a world leader in biosimilars

Express Pharma

JULY 3, 2023

For decades, Waters has been a trusted partner to many pharma and generics companies operating in India, particularly for small molecule QA/QC. India is known as the ‘Pharmacy of the World’, as the generic medicine supplier for over 200 countries, both developed and emerging markets. How poised are you to leverage them?

Biosimilars Drug Development Generic Medicine Immunization

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CHMP meeting highlights: April 2024

European Pharmaceutical Review

APRIL 30, 2024

CHMP biosimilar recommendations A positive opinion for Tofidence (tocilizumab) was adopted by the committee, indicated for rheumatoid arthritis, COVID-19, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. This covers paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease.

Generic Medicine

Generic Medicine Biosimilars Chemotherapy Hospitals

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CHMP meeting highlights – June 2024

European Pharmaceutical Review

JULY 1, 2024

The committee gave a positive opinion for the biosimilar Steqeyma (ustekinumab). Additionally, approval was recommended two generic medicines: Enzalutamide Viatris (enzalutamide) to treat prostate cancer, and Nilotinib Accord (nilotinib) was also recommended to treat Philadelphia chromosome positive chronic myelogenous leukaemia.

Generic Medicine

Generic Medicine Vaccines Biosimilars

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CHMP meeting highlights: February 2024

European Pharmaceutical Review

FEBRUARY 26, 2024

Other positive opinions by the CHMP Zynyz* (retifanlimab) as a treatment for Merkel cell carcinoma, a type of skin cancer Pyzchiva (ustekinumab), a biosimilar used to treat plaque psoriasis The generic medicine Apremilast Accord (apremilast), for psoriatic arthritis, psoriasis and Behçet’s disease, a rare type of inflammatory disease Generic medicine (..)

Generic Medicine

Generic Medicine Vaccines Pharmaceutical Companies Pharmaceutical Companies

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Standards support medicines supply chain resilience and the future of quality

Quality Matters

APRIL 20, 2023

Launched in 2021 and composed of more than 250 million data points spanning 92% of generic medicines approved in the U.S.,

Labelling Biosimilars Vaccines Generic Medicine

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CHMP meeting highlights – March 2023

European Pharmaceutical Review

APRIL 3, 2023

The CHMP adopted a positive opinion for Epysqli (eculizumab), a biosimilar medicine for paroxysmal nocturnal haemoglobinuria. Pedmarqsi is indicated in patients from one month up to 18 years old with localised, non-metastatic, solid tumours.

Chemotherapy Vaccines Generic Medicine Biosimilars

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EMA human medicines committee (CHMP) highlights, November 2022

European Pharmaceutical Review

NOVEMBER 14, 2022

Four medicines recommended for approval in the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP)’s latest meeting included a biosimilar for osteoporosis and a novel COVID-19 vaccine.

Vaccines Generic Medicine Biosimilars

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EMA human medicines committee (CHMP) highlights, September 2022

European Pharmaceutical Review

SEPTEMBER 21, 2022

Biosimilar medicine Ximluci (ranibizumab) for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease, causing gradual vision impairment, mainly in the elderly population. Teriparatide SUN (teriparatide) for the treatment of osteoporosis in adults.

Generic Medicine

Generic Medicine Vaccines Biosimilars

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Balancing MAGA and MIGA

Express Pharma

MARCH 3, 2025

According to him, Passing the PILLS Act is a necessary first step to reverse this trend, restore American pharmaceutical production, create high-quality jobs, and protect national security by ensuring a safe, reliable domestic supply of high-quality generic medicines, antibiotics, and other essential drugs.” Sounds familiar?

Generic Medicine

Generic Medicine Biosimilars

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CHMP meeting highlights – January 2025

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. New vaccine Vimkunya (chikungunya vaccine (recombinant, adsorbed)) was also recommended for individuals 12 years old and adults to prevent disease caused by the Chikungunya virus.

Generic Medicine

Generic Medicine Vaccines Chemotherapy Biosimilars