STAT

SEPTEMBER 24, 2024

Regeneron has accused Amgen of infringing dozens of patents with a biosimilar version of Eylea called Pavblu. sales in 2023. Regeneron has sued several other competitors over their proposed Eylea biosimilars, and brought its lawsuit against Amgen in January. Eylea earned Regeneron $5.89 billion in U.S.

Biosimilars 255

Biosimilars 255

Safe Biologics

DECEMBER 6, 2023

prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

PharmaVoice

OCTOBER 24, 2022

In Amgen's 2022 Biosimilars Trend Report, the company tracks the progress and potential of the copycat drugs as they reach a pivotal moment.

Biosimilars 203

Biosimilars 203

Safe Biologics

SEPTEMBER 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines. A biosimilar standard unique to the U.S.,

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JANUARY 12, 2024

The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

Biosimilars 130

Biosimilars Drug Pricing 130

STAT

APRIL 5, 2024

sales of its biosimilar version of AbbVie’s blockbuster arthritis treatment Humira , STAT reports. That led to less uptake of biosimilar versions of Humira in the U.S., … Boehringer Ingelheim will lay off an undisclosed number of sales reps due to poor U.S. including Boehringer’s Cyltezo.

Biosimilars 268

Biosimilars Vaccines Immunity Immunization 268

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). View the poster here.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). View the poster here.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

European Pharmaceutical Review

JANUARY 11, 2024

The European Commission (EC) has granted a marketing authorisation for Uzpruvo ® (AVT04) in Europe, a biosimilar candidate to Stelara ® (ustekinumab). A new European biosimilar approval “This first marketing authorisation for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition.

Biosimilars 115

Biosimilars Immunity Immunization 115

European Pharmaceutical Review

NOVEMBER 30, 2023

Biocon Biologics Ltd has successfully completed integration of Viatris’ biosimilar business in 31 European countries. Europe’s biosimilars market In Europe, Biocon Biologics portfolio includes seven biosimilars: Insulin Aspart and Insulin Glargine, Bevacizumab, Pegfilgrastim, Trastuzumab , Adalimumab , and Etanercept.

Biosimilars 111

Biosimilars 111

Drug Channels

MARCH 28, 2023

Click here to see the original post and comments from January 2023. For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. d/b/a Drug Channels Institute.

Biosimilars 96

Biosimilars 96

Safe Biologics

OCTOBER 10, 2023

Biosimilar for Multiple Sclerosis (MS) On August 25th, the FDA announced approval of Tyruko (natalizumab-sztn) the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko (natalizumab-sztn) is the 42nd biosimilar approved by the U.S.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Big Molecule Watch

JANUARY 18, 2024

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The Guide to Biosimilars Litigation and Regulation in the U.S.

Biosimilars 62

Biosimilars 62

European Pharmaceutical Review

JULY 21, 2023

To support future growth of its biosimilar pipeline, Sandoz is planning to build a Biosimilar Technical Development Center in Slovenia. With this financial boost, the Ljubljana site is set to become a key location for biosimilar product development at Sandoz.

Biosimilars 98

Biosimilars Drug Development 98

European Pharmaceutical Review

AUGUST 4, 2023

According to data and analytics company GlobalData , Boehringer Ingelheim’s Cyltezo has demonstrated the intersection of price and regulation in the biosimilars market. “Of This has developed following numerous adalimumab biosimilar offerings being brought to market. Worldwide sales for Humira peaked at $21.2

Biosimilars 97

Biosimilars 97

European Pharmaceutical Review

APRIL 11, 2024

percent CAGR between 2023 and 2032. Over the past few years, the biosimilar market has expanded “rapidly” due to these medicines offering a cost-effective alternative to the reference product. As of September 2022, there were around 39 biosimilars approved and 22 marketed, the report stated. million by 2032, at 17.6

Biosimilars 105

Biosimilars 105

Big Molecule Watch

OCTOBER 11, 2023

FDA grants interchangeable designation to Pfizer’s adaliumumab biosimilar – On October 5, 2023, Pfizer Inc. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). BI launched the product, marketed as CYLTEZO, in July 2023 at a 5% discount to HUMIRA.

Biosimilars 62

Biosimilars 62

LifeProNow

MARCH 24, 2023

March 21, 2023 : “Sandoz, a global leader in generic pharmaceuticals and biosimilars, today announced that the US Food and Drug Administration (FDA) approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz ® (adalimumab-adaz) injection. Head of North America. “As Head of North America.

Biosimilars 130

Biosimilars Immunity Immunization 130

Drug Channels

JANUARY 10, 2023

For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. Each exclusion list now contains about 600 products.

Biosimilars 93

Biosimilars 93

Express Pharma

DECEMBER 25, 2023

Intas Pharmaceuticals has signed an exclusive licensing agreement with mAbxience ( a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) for biosimilar for Etanercept. According to IQVIA, global sales of Etanercept for 12 months ending June 2023 is $11B.

Biosimilars 105

Biosimilars 105

European Pharmaceutical Review

MAY 10, 2023

Sandoz has announced it is investing €25 million in its manufacturing site in Holzkirchen, Germany, to expand its biosimilar development capabilities. The company intends to grow its Biopharma Technical Development (BioTD) capabilities and transform the lab building into a state-of-the-art biotech lab by the last quarter of 2023.

Biosimilars 98

Biosimilars 98

Big Molecule Watch

JUNE 5, 2024

In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars.

Biosimilars 62

Biosimilars 62

Safe Biologics

DECEMBER 1, 2023

From November 12-14, ASBM exhibited at Booth #2612 at ACR Convergence 2023 in San Diego, CA. Visitors to the booth learned about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines.

Drug Pricing 100

Drug Pricing Biosimilars 100

Big Molecule Watch

APRIL 19, 2024

launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation. As we previously reported , Fresenius Kabi received FDA approval for both intravenous and subcutaneous formulations on March 5, 2024, making TYENNE the first tocilizumab biosimilar approved in both formulations.

Biosimilars 62

Biosimilars 62

European Pharmaceutical Review

JUNE 9, 2023

Samsung Biologics, the South Korean contract development and manufacturing organisation (CDMO), has entered into a strategic partnership for the long-term commercial manufacturing of Pfizer’s multi-product biosimilars portfolio. The 240,000 litre biomanufacturing plant was completed earlier in June 2023. “We

Biosimilars 98

Biosimilars 98

Pharmaceutical Commerce

NOVEMBER 8, 2023

Session explores how on-market products have done, and what to expect from new biosimilars.

Biosimilars 105

Biosimilars 105

Drug Channels

OCTOBER 3, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on our new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Boehringer-Ingelheim launched an unbranded, low WAC version of its interchangeable biosimilar. The Humira biosimilar market has arrived!

Biosimilars 80

Biosimilars Drug Pricing Labelling 80

Big Molecule Watch

OCTOBER 4, 2024

On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI (ustekinumab-aauz), a biosimilar to STELARA®. and worldwide.”

Biosimilars 62

Biosimilars 62

PharmaShots

JUNE 7, 2023

Our team at PharmaShots has summarized 16 key events of the biosimilar space of May 2023 1. based on change from baseline on a standardized DAS28-CRP which evaluates the severity of RA using clinical and laboratory data Additionally, the company initiates PK study for AVT05 in Jan 2023. 84% vs 64%) & 2yr. (60%

Biosimilars 40

Biosimilars Packaging Diabetes Pharmaceutical Companies 40

Pharmacy Times

NOVEMBER 3, 2023

On this month's episode, Pharmacy Times covers the Academy of Managed Care Pharmacy Nexus 2023 conference, highlighting the updates on biosimilars.

Biosimilars 52

Biosimilars 52

Express Pharma

JUNE 22, 2023

Healthcare professionals (HCPs) believe that biosimilars could provide costs savings for the patients and healthcare systems and their use should be encouraged, according to a survey by GlobalData. The only exception was Japan were physicians seemed to be more reluctant about biosimilar use.

Biosimilars 98

Biosimilars 98

European Pharmaceutical Review

DECEMBER 12, 2023

The first stage of construction has officially begun on Lek Pharmaceuticals’ new biologics and biosimilars production centre in Lendava, north eastern Slovenia. Sandoz announced plans for the facility in March 2023. The new biosimilars production centre will also include facilities for manufacturing and storage.

Biosimilars 105

Biosimilars Packaging Pharmaceutical Companies Pharmaceutical Companies 105

European Pharmaceutical Review

AUGUST 25, 2023

The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. Tyruko (natalizumab-sztn) is a biosimilar to Tysabri (natalizumab) injection for adults with relapsing forms of MS. Approval of Tyruko has been granted to Sandoz Inc.

Biosimilars 98

Biosimilars 98

Big Molecule Watch

JULY 6, 2023

In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there are now 8 adalimumab biosimilar products available in the U.S.

Biosimilars 67

Biosimilars 67

Big Molecule Watch

MAY 19, 2023

On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab). On May 15, 2023, Boan Biotech announced the completion of patient enrollment for a Phase III clinical trial of the company’s Dulaglutide Injection (BA5101) in China.

Biosimilars 70

Biosimilars Diabetes 70

pharmaphorum

AUGUST 2, 2023

Samsung seeks 'interchangeable' label for Humira biosimilar Phil.Taylor Wed, 02/08/2023 - 10:37 Bookmark this

Labelling 98

Labelling Biosimilars 98

Express Pharma

AUGUST 1, 2023

The potential revenue replacing Humira has resulted in many adalimumab biosimilar offerings being brought forth (currently nine FDA-approved agents), and a rapidly overcrowded market. Against this backdrop, Cyltezo from Boehringer Ingelheim has shown the intersection of price and regulation in the biosimilar market, says GlobalData.

Biosimilars 98

Biosimilars 98