pharmaphorum

FEBRUARY 28, 2022

India’s Biocon has expanded its pipeline of biosimilars with a $3.3 Biocon’s partnership with Mylan – which merged with Pfizer’s Upjohn to form Viatris in 2020 – dates back more than a decade and has generated a number of biosimilars including insulin analogues, antibodies and recombinant proteins.

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Drug Channels

OCTOBER 6, 2020

The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. As I predicted last year, newer biosimilars are being adopted quickly, and their prices are declining rapidly.

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pharmaphorum

AUGUST 24, 2022

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The safety and immunogenicity profile of the biosimilar was also comparable to Alexion’s drug, said Amgen.

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Biosimilars Labelling 98

Drug Channels

DECEMBER 17, 2020

Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. Click here to see the original post and comments from October 2020. The biosimilar market is finally beginning to fulfill its promise. As I predicted last year, newer biosimilars are being adopted quickly, and their prices are declining rapidly.

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Biosimilars Drug Pricing 52

Eye on FDA

FEBRUARY 10, 2021

Looking now to a review of enforcement by the Office of Prescription Drug Promotion (OPDP) in 2020, we see a different picture. The collection of letters issued by OPDP during 2020 can be found here. We instead see the same pace as we have the past several years – that is anemic levels of enforcement.

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Communication Biosimilars Compounding 77

BioPharma Dive

MARCH 29, 2023

The pharmaceutical giant is asserting patents gained via its 2020 acquisition of Momenta in litigation to forestall entry of a biosimilar to its psoriasis drug Stelara.

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Biosimilars 80

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. billion respectively during 2020 as the pandemic reduced patient access to treatment.

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Biosimilars Labelling Diabetes 72

Big Molecule Watch

NOVEMBER 7, 2023

This webinar will explore topics including: Evolving trends of biologic patent challenges at the PTAB; Strategic considerations for biosimilar manufacturers; and Lessons learned from recent filings. The post Biosimilars Patent Challenges at the PTAB: Update and Lessons Learned appeared first on Big Molecule Watch.

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Biosimilars 69

Drug Channels

MAY 27, 2020

Before you venture outside for your lockdown barbeque, check out these noteworthy items off the Drug Channels grill: Payers predict how COVID-19 will affect formularies Our analysis of the 2020 retail-to-mail shift AmerisourceBergen profiles biosimilars Plus, CVS pharmacy offers a clever way to measure appropriate social distancing.

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Biosimilars Specialty Pharmacies Hospitals 52

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.”

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Biosimilars Packaging Labelling Drug Development 130

Express Pharma

JULY 14, 2023

herapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global phase III Intas Pharma announced that the European Medicine Agency (EMA) confirms acceptance of the Marketing Authorisation Application (MAA) for DMB-3115, a biosimilar of Stelara (Ustekinumab).

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Biosimilars 98

Safe Biologics

JANUARY 1, 2023

ASBM Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. Feldman explains unique features of the U.S. The bifurcated U.S.

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Biosimilars Drug Pricing 100

Drug Channels

JULY 29, 2020

In this issue: Pricing problems for diabetes treatments Controversy over Regeneron’s copay support Massachusetts concedes that coupons help some patients (but accumulators hurt) A 2020 update to my all-time favorite chart Plus, thoughtful perspectives on diversity from AmerisourceBergen CEO Steve Collis. d/b/a Drug Channels Institute.

Diabetes 52

Diabetes Biosimilars 52

Big Molecule Watch

APRIL 14, 2023

HLX02 was originally developed by Shanghai Henlius Biotech and was approved by the European Commission and China’s National Medical Products Administration (NMPA) in 2020. The post Accord BioPharma Announces the Acceptance of BLA for HLX02 (a proposed trastuzumab biosimilar) by FDA appeared first on Big Molecule Watch. and Canada.

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Biosimilars 59

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Biomm will gain exclusive rights for the distribution and marketing in Brazil of the proposed biosimilar to Janssen’s Stelara.

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Biosimilars 52

RX Note

DECEMBER 25, 2024

However, with the proliferation of biosimilars and liposomal or pegylated forms, health care professionals are now encouraged to communicate using product name for certain circumstances (e.g. bioavailability differences, release profile variations, biologics and biosimilars , licence variations and patient factors) to avoid confusion.

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Biosimilars Community Pharmacies Labelling Communication 52

pharmaphorum

FEBRUARY 24, 2021

Higher biosimilar savings. Spain, like many European countries, have seen biosimilars as a route to helping manage pressure on health care spending. Back in 2020 savings from biosimilars were forecasted to really get going in that year and through to 2022. Revalmed was formally launched in November 2020.

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Biosimilars Immunization Immunity 100

European Pharmaceutical Review

DECEMBER 19, 2022

A biosimilar is a biological medicine ‘similar’ to another biological medicine already approved in the EU (the ‘reference medicine’). 1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product.

Biosimilars 52

Biosimilars 52

Big Molecule Watch

MAY 22, 2023

Last week, Amneal announced the launch of FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Amgen’s NEULASTA, in the United States. Amneal developed FYLNETRA in collaboration with Kashiv Biosciences, a biopharmaceutical company located in Chicago, Illinois.

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Biosimilars Chemotherapy 72

Drug Channels

NOVEMBER 24, 2020

My recent tweets have highlighted: doctors against step therapy, distribution of COVID-19 therapies, biosimilar savings, copay accumulator data, prospects for smaller PBMs, the new transparency rule, specialty pharmacy profit metrics, the future of oncology practices, and an update on Diplomat founder Phil Hagerman. to 1:15 p.m.

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Specialty Pharmacies Biosimilars Hospitals 52

pharmaphorum

OCTOBER 16, 2020

Sales of its “big three” cancer drugs were all down considerably in Q3 as cheaper biosimilars gained market share in the US. All three are facing competition from several different biosimilars in the US, which have come to market over the last couple of years and after the cut price competitors hit the European market.

Biosimilars 52

Biosimilars 52

Drug Channels

JUNE 24, 2020

My recent tweets have highlighted: Amazon’s activities, PillPack’s bad reviews, 340B outrages, rebate reform redux, biosimilar pricing, managed Medicaid market shares, drug pricing, blockchain hype, and the warp speed vs. hyperspace debate. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Drug Pricing Biosimilars 52

Pharmaceutical Technology

JULY 15, 2022

In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin.

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Biosimilars Diabetes Documentation Packaging 131

pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention. The post FDA clears first “interchangeable” Humira biosimilar appeared first on.

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Biosimilars Labelling 40

Big Molecule Watch

APRIL 27, 2023

FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Biogen’s BPCIA case against Sandoz, related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab), is pending in the District of Delaware.

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Biosimilars 64

Pharma Pathway

FEBRUARY 26, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 85

Pharma Pathway

FEBRUARY 14, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 84

FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Biosimilars Labelling Communication 59

Pharma Pathway

DECEMBER 13, 2022

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Pass out year: 2019/ 2020/2021/ 2022. Dear, Greetings from Hetero…!!

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 80

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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Biosimilars Packaging Diabetes Hospitals 40

Pharma Pathway

SEPTEMBER 21, 2022

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Passout: 2020, 2021, 2022. On 24th Sept’ 2022 @ Hetero Labs Ltd.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 83

Pharma Pathway

SEPTEMBER 16, 2022

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Experience: 2019, 2020, 2021, 2022 passed outs only. Designation: Jr.

Biosimilars 79

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 79

Pharma Pathway

FEBRUARY 3, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 82

pharmaphorum

DECEMBER 13, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

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Biosimilars 111

Pharma Pathway

SEPTEMBER 13, 2022

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Eligibility: 2019, 2020, 2021, 2022 passed outs Only. Experience: Freshers.

Biosimilars 78

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 78

Pharma Pathway

DECEMBER 7, 2022

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Pass out year: 2020/ 21/ 22/ 23 (Final Sem Pursuing) Passed outs.

Biosimilars 87

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 87

Pharma Pathway

FEBRUARY 2, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world.

Biosimilars 80

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 80