2024, Biosimilars and Diabetes

Megablockbusters are the holy grail. Here’s how drugmakers are getting there.

PharmaVoice

JUNE 23, 2025

Voices Q&A Profiles Biotech Spotlight First 90 Days Opinions Topics Biotech Commercialization Leadership Manufacturing Patient Pharma Policy & Regulation Research & Development Library Events Press Releases PharmaVoice 100 Nominate 2024 PV100 2023 PV100 Sign up Search Sign up Search An article from Megablockbusters are the holy grail.

Diabetes

Diabetes Packaging Biosimilars

Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in

Pharmaceutical Technology

JUNE 23, 2025

Alvotech has moved one step closer to entering the Eylea (aflibercept 2 mg) biosimilar market, after a European Medicines Agency (EMA) panel recommended approval of its copycat biologic. Go deeper with GlobalData Reports LOA and PTSR Model - Aflibercept Biosimilar in Age Related Macular. CucuMberStudio via Shutterstock.

STAT+: Pharmalittle: We’re reading about Senate aides meeting with Novo Nordisk, private drug prices in Germany, and more

STAT

JULY 15, 2024

In April, the lawmakers wrote to the company expressing alarm at its decision, announced in November, that it would permanently discontinue Levemir by the end of 2024.

Drug Pricing

Drug Pricing Biosimilars Diabetes

Recent Biosimilar Approvals By the FDA

Big Molecule Watch

SEPTEMBER 27, 2024

Approval of Accord’s Trastuzumab Biosimilar : On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

Biosimilars

Biosimilars Dosage Diabetes

AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

MARCH 16, 2025

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands. and Europe. and Europe.

Aflibercept Biosimilar Updates in Europe

Big Molecule Watch

OCTOBER 4, 2024

On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s aflibercept biosimilar AFQLIR. On September 20, 2024, Samsung and Biogen announced that the CHMP also adopted a positive opinion for their aflibercept biosimilar OPUVIZ.

Biosimilars

Biosimilars Diabetes

EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting

Big Molecule Watch

AUGUST 6, 2024

The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. The post EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting appeared first on Big Molecule Watch.

Biosimilars

Biosimilars Diabetes

Novartis says trials back Beovu safety in diabetic eye disease

pharmaphorum

AUGUST 17, 2021

Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on the safety issue, with Beovu (brolucizumab) found to be roughly equivalent to Bayer and Regeneron’s Eylea (aflibercept) when it came to inflammatory reactions in the eye. of Beovu patients, compared to 1.7%

Diabetes

Diabetes Biosimilars

EU Biosimilar Regulatory and Launch Updates

Big Molecule Watch

FEBRUARY 7, 2025

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizationsforthree biosimilar productsAmgens PAVBLU and SKOJOY, and CuraTeQ Biologics DYRUPEG.

Biosimilars

Biosimilars Chemotherapy Diabetes

Data Supports Approval of Biosimilar Aflibercept for Diabetic Macular Edema

Pharmacy Times

OCTOBER 2, 2024

In May 2024, the first biosimilars for aflibercept were approved, which included aflibercept-jbvf (Yesafili; Biocon Biologics), known as MYL-1701P.

Biosimilars

Biosimilars Diabetes

Obesity drug tirzepatide approval in China strengthens market position amid GLP-1 agonist competition: GlobalData

Express Pharma

AUGUST 8, 2024

Benemae Pharmaceutical’s benaglutide injection (Feisumei) was the first innovator approved for obesity in July 2023 in China followed by Novo Nordisk’s diabetes therapy semaglutide (Wegovy) in June 2024. Tirzepatide’s US patent lasts until 2036, with no known biosimilars, even in China. Both are GLP-1 receptor agonists.

Biosimilars

Biosimilars Diabetes

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The post FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis appeared first on.

Biosimilars

Biosimilars Labelling Diabetes

FDA Approves Ustekinumab, Aflibercept, and Filgrastim Biosimilars

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.

Biosimilars

Biosimilars Diabetes

Towards a healthier, more equitable and innovative Indian healthcare sector

Express Pharma

NOVEMBER 1, 2024

The Union Health Ministry received an allocation of about Rs 90,650 crores in the recent budget of 2024-25, a 12.5 Establishing Centers of Excellence and leveraging artificial intelligence for pharma research can advance India’s capabilities in NCEs, biologics, and biosimilars, placing it at the forefront of global pharma innovation.

Insurance Coverage and Processing

Insurance Coverage and Processing Biosimilars Communication Diabetes

Grail plans FDA filing for cancer blood test after new trial

pharmaphorum

JUNE 20, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept

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.”

Biosimilars

Biosimilars Diabetes Dosage

Sandoz to Acquire CIMERLI from Coherus for $170 Million

Big Molecule Watch

FEBRUARY 6, 2024

On January 22, 2024, Sandoz announced its plans to acquire the U.S. biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. According to Sandoz, “closing is anticipated in 1H 2024, subject to standard conditions and approval.” Coherus”) for an upfront cash purchase payment of USD 170 million.

Biosimilars

Biosimilars Diabetes

Mapping the crisis: How data can help fix America’s growing pharmacy deserts

pharmaphorum

JUNE 12, 2025

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Health and Personal Care Stores

Health and Personal Care Stores Diabetes Pharmaceutical Companies Pharmaceutical Companies

Vor Bio revives, thanks to $4bn+ licensing deal with RemeGen

pharmaphorum

JUNE 26, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

European Commission Approves Samsung Bioepis and Biogen’s Aflibercept Biosimilar

Big Molecule Watch

NOVEMBER 27, 2024

On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ. OPUVIZ is the second EC-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership.

Biosimilars

Biosimilars Diabetes

Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

Big Molecule Watch

DECEMBER 21, 2023

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. 10,888,601 (“the ’601 Patent”), challenging claims directed to methods of treating diabetic macular edema (“DME”) and diabetic retinopathy (“DR”).

Biosimilars

Biosimilars Diabetes

Barriers are limiting UK childhood vaccination, say doctors

pharmaphorum

JULY 1, 2025

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Vaccines

Vaccines Diabetes Pharmaceutical Companies Pharmaceutical Companies

Caris swells its planned IPO, seeking $5.7bn valuation

pharmaphorum

JUNE 17, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

ADA: Lilly makes its case for oral GLP-1 orforglipron

pharmaphorum

JUNE 23, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Updates on Aflibercept Biosimilar Approvals and BPCIA Litigation

Big Molecule Watch

JUNE 7, 2024

FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s

Biosimilars

Biosimilars Diabetes Labelling

‘Insulin for muscle’ and the AI platform behind it, with Hanadie Yousef

pharmaphorum

JUNE 27, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

The Inaugural Multi-Omics Based Drug Discovery & Development

pharmaphorum

JULY 1, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Maximising value by uniting the digital backbone: On a new Novo Nordisk and Veeva partnership

pharmaphorum

JULY 1, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Most pharmas not ready for AI in customer engagement

pharmaphorum

JUNE 10, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Breaking: Judgment in Regeneron v. Mylan (aflibercept) BPCIA Case Finding Some Claims of Asserted Patents Valid and Infringed

Big Molecule Watch

DECEMBER 28, 2023

As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. At trial, Regeneron asserted infringement of claims 6 and 25 of U.S.

Biosimilars

Biosimilars Diabetes

Nektar eyes pivotal trials for eczema drug cast off by Lilly

pharmaphorum

JUNE 26, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Update: Rumour confirmed as Lilly buys Verve Therapeutics

pharmaphorum

JUNE 17, 2025

billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023. billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023.

Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

2nd Translational Digital Pathology & AI Summit

pharmaphorum

JUNE 27, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Why security-first design is the fix to stalling AI pilot tools

pharmaphorum

JULY 2, 2025

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Diabetes

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7th TRP Europe | November 2025, Amsterdam | Agenda Released

pharmaphorum

JUNE 25, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

8th Neuropsychiatric Drug Development Summit

pharmaphorum

JUNE 27, 2025

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Drug Development

Drug Development Diabetes Pharmaceutical Companies Pharmaceutical Companies

ACIP backs block on flu vaccines with thimerosal additive

pharmaphorum

JUNE 26, 2025

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Vaccines

Vaccines Diabetes Pharmaceutical Companies Pharmaceutical Companies

16th World ADC San Diego 2025

pharmaphorum

JUNE 20, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

13th IMPACCT Real-World Evidence Summit

pharmaphorum

JUNE 24, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Drug Development

The Obesity Drug Development Summit has landed in Europe!

pharmaphorum

JUNE 27, 2025

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Drug Development

Drug Development Diabetes Pharmaceutical Companies Pharmaceutical Companies

AbbVie's $2.1bn buy of Capstan lifts its immunology pipeline

pharmaphorum

JULY 1, 2025

billion, expanding its pipeline with a potential first-in-class treatment for autoimmune diseases as well as adding a novel RNA delivery system to its portfolio. billion, expanding its pipeline with a potential first-in-class treatment for autoimmune diseases as well as adding a novel RNA delivery system to its portfolio.

Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Immunity

Expanding Pneumococcal Vaccinations to Healthy Adults Aged 50 to 64 Years Offers Significant Health, Economic Benefits

Pharmacy Times

JUNE 20, 2025

Prior to October 2024, the Advisory Committee on Immunization Practices (ACIP) recommended use of a PCV only for all adults aged 65 years and older, including those aged 19 to 64 years with risk conditions for pneumococcal disease.

Vaccines

Vaccines Pharmacy Technician Immunity Immunization

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

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).

After rebuffing Biogen, Sage pairs off with Supernus

pharmaphorum

JUNE 16, 2025

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Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Megablockbusters are the holy grail. Here’s how drugmakers are getting there.

Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in

Trending Sources

STAT+: Pharmalittle: We’re reading about Senate aides meeting with Novo Nordisk, private drug prices in Germany, and more

Recent Biosimilar Approvals By the FDA

AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Aflibercept Biosimilar Updates in Europe

EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting

Novartis says trials back Beovu safety in diabetic eye disease

EU Biosimilar Regulatory and Launch Updates

Data Supports Approval of Biosimilar Aflibercept for Diabetic Macular Edema

Obesity drug tirzepatide approval in China strengthens market position amid GLP-1 agonist competition: GlobalData

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

FDA Approves Ustekinumab, Aflibercept, and Filgrastim Biosimilars

Towards a healthier, more equitable and innovative Indian healthcare sector

Grail plans FDA filing for cancer blood test after new trial

Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept

Sandoz to Acquire CIMERLI from Coherus for $170 Million

Mapping the crisis: How data can help fix America’s growing pharmacy deserts

Vor Bio revives, thanks to $4bn+ licensing deal with RemeGen

European Commission Approves Samsung Bioepis and Biogen’s Aflibercept Biosimilar

Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

Barriers are limiting UK childhood vaccination, say doctors

Caris swells its planned IPO, seeking $5.7bn valuation

ADA: Lilly makes its case for oral GLP-1 orforglipron

Updates on Aflibercept Biosimilar Approvals and BPCIA Litigation

‘Insulin for muscle’ and the AI platform behind it, with Hanadie Yousef

The Inaugural Multi-Omics Based Drug Discovery & Development

Maximising value by uniting the digital backbone: On a new Novo Nordisk and Veeva partnership

Most pharmas not ready for AI in customer engagement

Breaking: Judgment in Regeneron v. Mylan (aflibercept) BPCIA Case Finding Some Claims of Asserted Patents Valid and Infringed

Nektar eyes pivotal trials for eczema drug cast off by Lilly

Update: Rumour confirmed as Lilly buys Verve Therapeutics

2nd Translational Digital Pathology & AI Summit

Why security-first design is the fix to stalling AI pilot tools

7th TRP Europe | November 2025, Amsterdam | Agenda Released

8th Neuropsychiatric Drug Development Summit

ACIP backs block on flu vaccines with thimerosal additive

16th World ADC San Diego 2025

13th IMPACCT Real-World Evidence Summit

The Obesity Drug Development Summit has landed in Europe!

AbbVie's $2.1bn buy of Capstan lifts its immunology pipeline

Expanding Pneumococcal Vaccinations to Healthy Adults Aged 50 to 64 Years Offers Significant Health, Economic Benefits

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

After rebuffing Biogen, Sage pairs off with Supernus

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