Content about Biosimilar

November 19, 2012

The year 2012 is coming to an end, and it's been a big year for generic drugs. It's the year that the most lucrative drug of all time became commoditized. It's the year that Watson bought Actavis for $5.6 billion. And it's the year the FDA released draft guidance for biosimilars regulations. All of these events speak to some of the most important trends in the world of generics — trends that are often interrelated.

The year 2012 is coming to an end, and it's been a big year for generic drugs. It's the year that the most lucrative drug of all time became commoditized. It's the year that Watson bought Actavis for $5.6 billion. And it's the year the FDA released draft guidance for biosimilars regulations. All of these events speak to some of the most important trends in the world of generics — trends that are often interrelated.

 

April 14, 2014

The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

WASHINGTON — The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

The Delaware State Senate passed Senate Substitute 1 for Senate Bill 118. 

March 27, 2014

Indiana Governor Mike Pence earlier this week signed legislation designed to create a pathway for the substitution of interchangeable biologic medicines, according to published reports.

INDIANAPOLIS — Indiana Governor Mike Pence earlier this week signed legislation designed to create a pathway for the substitution of interchangeable biologic medicines, according to published reports. 

The bill allows a pharmacist to substitute an interchangeable biosimilar product for a prescribed biological product if certain conditions are met. It requires the board of pharmacy to maintain a website that lists the biosimilar biological products that are determined to be interchangeable. 

The specific conditions include: 

March 27, 2014

In lead-up to a House Panel hearing on Thursday, the National Association of Chain Drug Stores submitted a statement expressing its support for the leadership and efforts of Congress and the Food and Drug Administration in taking common-sense approaches in safeguarding the process of delivering prescription medications to patients.

ARLINGTON, Va. — In lead-up to a House Panel hearing on Thursday, the National Association of Chain Drug Stores submitted a statement expressing its support for the leadership and efforts of Congress and the Food and Drug Administration in taking common-sense approaches in safeguarding the process of delivering prescription medications to patients.

March 25, 2014

Sales of specialty medicines are shifting toward hospitals and specialty pharmacies and away from independent physician owned-and-operated clinics, according to a report released Tuesday by HDMA's non-profit research foundation, The Center for Healthcare Supply Chain Research.

ARLINGTON, Va. — Sales of specialty medicines are shifting toward hospitals and specialty pharmacies and away from independent physician owned-and-operated clinics, according to a report released Tuesday by HDMA's non-profit research foundation, The Center for Healthcare Supply Chain Research. 

According to the report, independent clinics commanded 59% of distributor sales in 2012, down from 66% in 2011. Sales to hospitals and specialty pharmacies, on the other hand, increased by 6% (combined) to comprise an average of 26% of specialty distributors’ sales. 

March 10, 2014

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines.

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines. By the end of this decade, a significant number of blockbuster drugs will go off patent, paving the way for biosimlar market entrance.

February 18, 2014

From 2012 to 2017, global spending on medicines will increase from $205 billion to $235 billion, according to IMS Health. By 2017, 36% of the spend will be on generics, a number that is 9% more than the percentage in 2013.

From 2012 to 2017, global spending on medicines will increase from $205 billion to $235 billion, according to IMS Health. By 2017, 36% of the spend will be on generics, a number that is 9% more than the percentage in 2013.

As a result of the patent cliff, generic drug manufacturers have thrived while branded pharmaceutical manufacturers have suffered. Branded pharmaceutical manufacturers are expected to suffer even more in the coming years, as many more important patents will lose exclusivity.

February 11, 2014

The Generic Pharmaceutical Association announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1, because it will allow unimpeded patient access to interchangeable biologics.

WASHINGTON — The Generic Pharmaceutical Association on Tuesday announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1,  because it will allow unimpeded patient access to interchangeable biologics. The bill mirrors current pharmacy practice for interchangeable generic substitution language, and is aligned with Food and Drug Administration definitions, the association noted.

February 3, 2014

The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.

WASHINGTON — The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization. 

February 3, 2014

Mylan on Monday announced that its subsidiary has launched the world's first trastuzumab biosimilar in India, which will be marketed by Mylan as Hertraz.

MUMBAI and PITTSBURGH — Mylan on Monday announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched the world's first trastuzumab biosimilar in India. The product — which will be marketed by Mylan as Hertraz — is used for the treatment of HER2-positive metastatic breast cancer. Hertraz is a biosimilar to Roche's Herceptin and is available in two strengths:  440mg and 150mg.

January 31, 2014

Actavis on Friday announced a realignment of its global strategic business structure to maximize the company's newly strengthened position as a leading specialty pharmaceutical developer, manufacturer and marketer, and to enhance Actavis' position for continued long-term growth.

DUBLIN — Actavis on Friday announced a realignment of its global strategic business structure to maximize the company's newly strengthened position as a leading specialty pharmaceutical developer, manufacturer and marketer, and to enhance Actavis' position for continued long-term growth. 

January 31, 2014

The imminent entry of several companies — including big pharma, small biotech and generic participants — into the global biosimilars space will propel the market toward exponential growth. The market is expected to soar from $1.2 billion in 2013 to $24 billion in 2019, reported Frost & Sullivan in research released earlier this week.

LONDON — The imminent entry of several companies — including big pharma, small biotech and generic participants — into the global biosimilars space will propel the market toward exponential growth. The market is expected to soar from $1.2 billion in 2013 to $24 billion in 2019, reported Frost & Sullivan in research released earlier this week. 

January 31, 2014

The Biotechnology Industry Organization and the Indiana Health Industry Forum commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

WASHINGTON — The Biotechnology Industry Organization and the Indiana Health Industry Forum on Thursday commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

The policies outlined in the identical SB 262 align with BIO’s principles on biologic substitution, therefore BIO and IHIF support passage of this bill as it moves along for consideration by the Indiana House of Representatives.

January 28, 2014

The Generic Pharmaceutical Association on Tuesday announced the hiring of Jonathan Marks as VP international affairs.

WASHINGTON — The Generic Pharmaceutical Association on Tuesday announced the hiring of Jonathan Marks as VP international affairs. Marks brings to GPhA more than 20 years of experience, including previous roles within the Department of Commerce. 

January 16, 2014

The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

WASHINGTON — The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

January 14, 2014

Three drug makers are looking into buying Pfizer's branded-generics drug business, according to published reports.

NEW YORK — Three drug makers are looking into buying Pfizer's branded-generics drug business, according to published reports.

Reuters reported that Actavis, Valeant Pharmaceuticals International and Mylan had expressed interest in buying Pfizer's business segment focused on generic drugs. However, Reuters reported that Pfizer was not yet ready to make a deal and was in the process of a potential separation of the generics unit.

January 14, 2014

Drug maker Sandoz has started a late-stage clinical trial of a biotech drug used to treat autoimmune disorders, the company said.

HOLZKIRCHEN, Germany — Drug maker Sandoz has started a late-stage clinical trial of a biotech drug used to treat autoimmune disorders, the company said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the start of a phase-3 clinical trial of biosimilar adalimumab. The drug is a version of AbbVie's Humira, used to treat rheumatoid arthritis, psoriasis and Crohn's disease.

December 26, 2013

Earlier this year, the IMS Institute for Healthcare Informatics, the research wing of the healthcare industry analysis firm IMS Health, dropped a bombshell when it showed that U.S. spending on drugs fell in 2012, the first time that had happened in 55 years.

Earlier this year, the IMS Institute for Healthcare Informatics, the research wing of the healthcare industry analysis firm IMS Health, dropped a bombshell when it showed that U.S. spending on drugs fell in 2012, the first time that had happened in 55 years. But according to IMS’ latest figures, it was not the start of a trend.

December 17, 2013

Forty blockbuster drugs will use patent exclusivity in the United States between this year and 2020, according to a new study.

BURLINGTON, Mass. — Forty blockbuster drugs will use patent exclusivity in the United States between this year and 2020, according to a new study.

November 26, 2013

Generic drug maker Hospira will have its investor conference next week, the company said Tuesday.

LAKE FOREST, Ill. — Generic drug maker Hospira will have its investor conference next week, the company said Tuesday.

The drug maker, based in the Chicago area, will have the investor day at its headquarters on Dec. 5. Hospira specializes in manufacturing injectable generic drugs, including biosimilars for the European market.

The event will include slide presentations, and the company will stream it via audio webcast at its investors website, hospirainvestor.com.

 

November 18, 2013

The global market for biosimilars is expected to be worth nearly $2 billion before the end of the decade, according to a new study.

DALLAS — The global market for biosimilars is expected to be worth nearly $2 billion before the end of the decade, according to a new study.

MarketsandMarkets, a Dallas-based research company, looked at the global market for biosimilars - knock-off versions of biotech drugs - including monoclonal antibodies, erythropoietins, recombinant proteins and peptides, forecasting $1.954 billion in market value by 2018.

November 12, 2013

Hospira had sales of $1 billion in third quarter 2013, the generic drug maker said.

LAKE FOREST, Ill. — Hospira had sales of $1 billion in third quarter 2013, the generic drug maker said.

Hospira, which specializes in making generic injectable drugs, as well as biosimilars for the European market, said the sales figures for the quarter were a 1.4% increase over the $994 million in sales reported in third quarter 2012. Profits for the quarter were $84.5 billion, compared with $78.4 billion during the same period last year.

November 5, 2013

A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

LAKE FOREST, Ill. — A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

October 29, 2013

In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

October 25, 2013

Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.

NEW YORK — Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.