Pharmaceutical Technology

DECEMBER 20, 2022

This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. However, the company is anticipated to experience recovery as it awaits regulatory approval from the FDA, expected in May 2023, after receiving priority review for its respiratory syncytial virus (RSV) vaccine.

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pharmaphorum

FEBRUARY 23, 2022

Adoption of biosimilars in the US has been notoriously slow, but biosimilars manufacturers and outside observers expect this to change rapidly in the coming years. One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars. The short story so far.

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Express Pharma

NOVEMBER 26, 2024

Namit Joshi, Vice Chairman, Pharmexil, said, “The Indian pharmaceutical industry has solidified its global position as the ‘Pharmacy of the World’ and earned recognition as the ‘Healers of the World’ through its exceptional contribution to COVID-19 vaccine distribution. With exports nearing $27.84

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Packaging Biosimilars Pharmaceutical Manufacturing Dosage 105

Express Pharma

JULY 3, 2023

Many millions of people are vaccinated against COVID-19, thanks to a messenger RNA (mRNA) encapsulated within a lipid nanoparticle. 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.

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Quality Matters

JUNE 17, 2024

Biologics and biosimilars – the basics Biologic medicines – “biologics” for short. And what about “biosimilars” ? Read on to learn some of the basics about biologics, biosimilars and why patients taking them can be confident in their quality. What are biosimilars? You’ve probably seen commercials for some of them on TV.

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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.

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Express Pharma

DECEMBER 20, 2024

Renowned for its extensive production of generic drugs and vaccines, the sector has played a pivotal role in addressing global healthcare demands. As of 2024, India has produced nearly half of the eight billion vaccine doses distributed worldwide, cementing its reputation as a reliable healthcare contributor.

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pharmaphorum

SEPTEMBER 8, 2020

In my role at Sandoz, I work with teams that are passionately trying to drive healthcare sustainability through the increased use of high-quality biosimilars. 7 With a typical price difference between reference biologics and biosimilars in the range of -15% to -80%, the immediate potential budget impacts are in the tens of billions.

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STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. The first therapy that delays the onset of type 1 diabetes received approval from the U.S. As of 2019, about 1.9

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Diabetes Biosimilars Documentation Compounding 246

pharmaphorum

MARCH 31, 2022

German injectable medicines specialist Fresenius Kabi has made a pair of deals to kickstart its new strategic direction, including a majority stake in mAbxience that bolsters its position in biosimilars. The post Deals build Fresenius Kabi’s position in biosimilars, medtech appeared first on.

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Express Pharma

FEBRUARY 13, 2025

Scientific sessions focused on regulatory policies, mRNA technology, cell therapy, biologics and biosimilars, biomanufacturing, and analytical validation. The conference also featured BioPitch, a platform for biotech startups, and Catalyst Connect Hour, facilitating networking opportunities.

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Express Pharma

JUNE 28, 2024

Our leadership in vaccine supply to WHO, coupled with meeting the generics demands of the USA, Britain, and Europe, underscores our pivotal role in healthcare accessibility. The significant growth in biosimilars approvals and manufacturing further enhances patient access to biopharmaceuticals.

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Packaging Biosimilars Labelling Vaccines 105

Pharmaceutical Technology

OCTOBER 28, 2022

Practising QbD in biosimilar product development. One area in which QbD should be practised is that of biosimilars, also known as follow-on biologics or subsequent entry biologics. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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Biosimilars Vaccines Drug Development Documentation 52

pharmaphorum

AUGUST 25, 2022

The Swiss pharma group said this morning that the separation “is in the best interest of shareholders” and will create the number one generics company in Europe and a leader in biosimilars, whilst allowing Novartis to focus on its patented medicines business. billion by 2024.

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Express Pharma

JULY 15, 2024

We believe that implementing a fresh PLI scheme for vaccines and biopharmaceutical raw materials is vital now to put the focus back on value-added domestic production with India-for-India and India-for-the-world production. This would stimulate new investments in both R&D and production initiatives.

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Express Pharma

JANUARY 3, 2025

Investing in cutting-edge research, particularly in biosimilars, novel biologics, and cell and gene therapies, will be crucial. Serum Institute of India (SII) is the worlds largest vaccine manufacturer. India is the largest vaccine producer in the world and accounts for 60 per cent of the global vaccine production.

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Express Pharma

DECEMBER 18, 2024

Additionally, the industry is set to make notable progress in cutting-edge areas such as CAR-T cell therapy, mRNA vaccines, and the development of complex molecules, which hold immense potential for driving future growth. The patent expiries of blockbuster biologics by 2025 present a significant growth avenue in the global biosimilars market.

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European Pharmaceutical Review

NOVEMBER 6, 2023

Demand for cell lines “in drug development , vaccine production, and therapeutic research is surging”, setting the market up for significant expansion, Ghosh noted. The increased spending on biosimilar R&D from exiting biopharmaceutical companies would enhance the market, the report stated.

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pharmaphorum

OCTOBER 20, 2021

In the first half the company had suggested diagnostic sales may start to flag in the latter half of the year as vaccinations started to bring COVID-19 infections under control, but it now expects high demand to continue into 2022. Diagnostics sales rose 39% to CHF 13.3 billion ($14.4 Group sales rose 8% to CHF 46.7

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Express Pharma

JANUARY 12, 2024

With the Indian Pharma sector trying to reach the USD 130 Billion target by 2030, there is a renewed spirit of research in the areas of cell and gene therapy, biologics and biosimilars apart from the already strong generic and vaccine manufacturing sectors of the country.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

The company told GlobalData PharmSource: “The biosimilar facilities in Austria and Slovenia would continue to manufacture biosimilars for Sandoz under a contractual agreement with Novartis. This came after an attempted sell-off starting last October was met with no formal offers from a buyer.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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pharmaphorum

JANUARY 27, 2023

The recent reversal of China’s “zero Covid” policy, at a time when the country still lacks optimal vaccine coverage, has also created another unknown, in terms of global supply and demand forecasting. About the author Richard Saynor was appointed CEO of Sandoz in 2019, a Novartis generics and biosimilars division.

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Packaging Biosimilars Vaccines 105

European Pharmaceutical Review

JANUARY 9, 2023

It determined that the industry’s leading players face a growth gap over the next five years as a wave of market-leading biopharmaceuticals lose patent exclusivity and face market competition from cheaper generic and biosimilar products.

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European Pharmaceutical Review

AUGUST 21, 2023

Part of this growth was driven by Arexvy, which in May 2023, became the world’s first approved RSV vaccine for older adults. This is mainly due to the reported decline in sales of Humira, a consequence of biosimilar competition. Merck & Co Merck & Co reached third in ranking, due to 8.4

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European Pharmaceutical Review

MARCH 2, 2023

Bekemv (eculizumab), the first biosimilar approved for this active substance received a positive opinion for paroxysmal nocturnal haemoglobinuria. CHMP COVID-19 updates The committee recommended authorising the use of COVID-19 Vaccine Valneva (inactivated, adjuvanted) as a booster dose for adults 18 to 50 years of age.

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European Pharmaceutical Review

APRIL 11, 2023

The key drivers of this industry include advancements in bioprocessing, development of novel microbial strains for production of high-value compounds and the rising demand for biopharmaceutical products such as antibiotics, vaccines and enzymes. There is a growing trend toward production of biologics and biosimilars.

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European Pharmaceutical Review

OCTOBER 27, 2022

For a market dominated by biosimilars and biobetters this means a cooling of valuations and gradual structural changes. The report also identified China’s much feted bio market as one that is going through a gradual ‘maturation stage’, with relatively lower growth rates likely in the next few years.

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Pharmaceutical Technology

JANUARY 30, 2023

While unbranded generics, sales from smaller companies, and centrally procured products (including vaccines and pandemic-related medicines) are excluded from the VPAS (and are unregulated, being open to free competition), the VPAS still covers a major proportion of pharmaceutical sales in the UK. For 2019–23, this was capped at 2% per year.

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Express Pharma

JUNE 5, 2023

It has often been the leader in areas, such as the manufacture of generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research and manufacturing, biosimilars, and biologics.

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PharmaShots

FEBRUARY 17, 2023

Iveric Bio Reports the US FDA Acceptance of NDA and Granted Priority Review of Avacincaptad Pegol for Geographic Atrophy Date: Feb 17, 2023 | Tags: Iveric Bio, Avacincaptad Pegol, Geographic Atrophy, Regulatory, US, FDA, NDA, Priority Review ALX Oncology Reports the First Patient Dosing of Evorpacept in the P-I Study (ASPEN-07) for the Treatment of (..)

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Pharmaceutical Technology

JANUARY 30, 2023

However, non-NME and biosimilar approvals increased in 2022. In 2023, there will be opportunities for a wider range of CMOs that can offer services for less innovative drugs requiring reformulation or biosimilar production. There were 38 innovator and biosimilar orphan drug approvals for the US in 2022.

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Biosimilars Diabetes Chemotherapy Vaccines 52

pharmaphorum

FEBRUARY 3, 2022

Roche has warned that revenue growth will come under pressure in the coming year as sales of its COVID-19 testing kits start to slow, exposing the impact of biosimilar competition to some of its top-selling drugs. The Swiss pharma group expects sales of its COVID-19 diagnostics and medicines to fall to around CHF 5 billion ($5.4

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Express Pharma

OCTOBER 9, 2024

He put forth the importance of Research and Development and regulatory systems, particularly for the deeper work needed in the biologics and biosimilar space. Reflecting on lessons from the last pandemic, he emphasised the importance of industrial capabilities, including manufacturing vaccines across multiple platforms.

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PharmaShots

MAY 19, 2023

SPAC Merger for ~$135M Date: May 18, 2023 | Tags: enGene, Forbion European Acquisition Corp, detalimogene voraplasmid, EG-70, BCG-unresponsive, non-muscle invasive bladder cancer, M&A, SPAC, Merger, ~$135M Roche Reports P-II Study (FENopta) Results of Fenebrutinib for the Treatment of Multiple Sclerosis Date: May 18, 2023 | Tags: Roche, Fenebrutinib, (..)

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Medical Schools Biosimilars Immunity Immunization 40

European Pharmaceutical Review

JULY 1, 2024

the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions” A positive opinion was granted to the mResvia (Respiratory Syncytial Virus (RSV) mRNA vaccine). The committee gave a positive opinion for the biosimilar Steqeyma (ustekinumab). 1 virus variant.

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pharmaphorum

FEBRUARY 8, 2022

Pfizer reckons it will make a whopping $22 billion in sales of its oral COVID-19 antiviral Paxlovid in 2022, with another $32 billion from its BioNTech-partnered coronavirus vaccine Comirnaty. It’s time to suspend intellectual property and break vaccine monopolies,” said the campaign group’s pharma head Tim Bierley.

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