Content about Biosimilar

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

October 17, 2013

As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

NEW YORK — The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

October 10, 2013

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

Last month, the company — which specializes in making generic injectable drugs — announced that European Union regulators had approved the continent’s first biosimilar monoclonal antibody.

October 7, 2013

A trade group of generic drug makers is hoping that California's governor vetoes a bill that it says would restrict patients' access to biosimilars.

NEW YORK — A trade group of generic drug makers is hoping that California's governor vetoes a bill that it says would restrict patients' access to biosimilars.

September 19, 2013

A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

WASHINGTON — A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

September 10, 2013

The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

September 10, 2013

European regulators have approved the European Union's first biosimilar monoclonal antibody. The new product, made by U.S.-based Hospira, comes seven years after the approval of Europe's first biosimilar.

LEAMINGTON SPA, United Kingdom — European regulators have approved the European Union's first biosimilar monoclonal antibody. The new product, made by U.S.-based Hospira, comes seven years after the approval of Europe's first biosimilar.

Hospira announced Tuesday the European Medicines Agency's approval of Inflectra (infliximab) for the treatment of autoimmune disorders like rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis.

September 10, 2013

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff.

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff. One of the reasons why generic prescriptions will likely peak at 86% to 87%, Long said, is that after the patent on Crestor expires In 2016, there simply won't be a lot of top-selling branded drugs.

August 29, 2013

The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

NEW YORK — The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

Biopharma-Reporter.com quoted an FDA spokeswoman as saying "efforts to undermine trust in these products" were cause for worry and did not serve the interests of patients.

August 27, 2013

Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

NEW YORK — Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

August 22, 2013

A bill under consideration by California's state legislature contains provisions that would place restrictions on pharmacists' ability to dispense knock-off versions of biotech drugs, drawing opposition from the generic pharmaceutical lobby and the state's pension fund for government employees.

SACRAMENTO, Calif. — A bill under consideration by California's state legislature contains provisions that would place restrictions on pharmacists' ability to dispense knock-off versions of biotech drugs, drawing opposition from the generic pharmaceutical lobby and the state's pension fund for government employees.

August 20, 2013

Generic drug maker Sandoz has relaunched a website to promote its biosimilars business.

NEW YORK — Generic drug maker Sandoz has relaunched a website to promote its biosimilars business.

August 8, 2013

The world is turning generic. That's the takeaway from the latest trends in the drug industry, according to IMS Health.

The world is turning generic. That's the takeaway from the latest trends in the drug industry, according to IMS Health. In 2012, according to the healthcare industry analytics firm, dollar sales of drugs fell by 1% to $325.7 billion, but prescriptions grew by 1.2% as generic drugs' share of total drugs dispensed grew to nearly 83%.

July 22, 2013

An announcement Monday by generic drug maker Sandoz gives a glimpse of what could happen in the United States when biosimilars start to become available.

HOLZKIRCHEN, Germany — An announcement Monday by generic drug maker Sandoz gives a glimpse of what could happen in the United States when biosimilars start to become available.

July 12, 2013

The creation of a clear approval pathway for biosimilar drugs remains a daunting task for the Food and Drug Administration, despite the fact that it's prescribed by law through the Patient Protection and Affordable Care Act. But when those lower-priced, generic versions of some staggeringly expensive bioengineered medicines do finally come to market, they're likely to have a profound effect on the nation's outlays for specialty pharmaceuticals.

The creation of a clear approval pathway for biosimilar drugs remains a daunting task for the Food and Drug Administration, despite the fact that it's prescribed by law through the Patient Protection and Affordable Care Act. But when those lower-priced, generic versions of some staggeringly expensive bioengineered medicines do finally come to market, they're likely to have a profound effect on the nation's outlays for specialty pharmaceuticals.

July 2, 2013

Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

HOLZKIRCHEN, Germany — Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started a phase-3 trial of biosimilar etanercept, a knock-off version of Amgen's Enbrel, used to treat chronic plaque-type psoriasis.

June 3, 2013

Another bill to limit dispensing of biosimilars lost Monday, this time in Illinois.

WASHINGTON — Another bill to limit dispensing of biosimilars lost Monday, this time in Illinois.

The state's legislature voted not to advance S.B. 1934, supported by such biotech companies as Amgen and Genentech, which would slow patients' access to knock-off versions of biotech drugs by restricting pharmacists' ability to dispense them. Illinois is the 13th state to defeat such a bill; a similar bill died in Texas' state legislature last week.

May 30, 2013

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

May 30, 2013

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

May 29, 2013

Texas has become the latest state to defeat a bill that critics say would limit the reach of knock-off versions of biotech drugs.

WASHINGTON — Texas has become the latest state to defeat a bill that critics say would limit the reach of knock-off versions of biotech drugs.

May 21, 2013

Spending on specialty drugs is likely to increase by 67% over the next couple of years, according to a new study by pharmacy benefit manager Express Scripts.

ST. LOUIS — Spending on specialty drugs is likely to increase by 67% over the next couple of years, according to a new study by pharmacy benefit manager Express Scripts.

May 17, 2013

Hospira has reappointed its chief scientific officer after he briefly left the country earlier this year, the generic drug maker said.

LAKE FOREST, Ill. — Hospira has reappointed its chief scientific officer after he briefly left the country earlier this year, the generic drug maker said.

Sumant Ramachandra has been reappointed to the position, effective Friday, and will be in charge of the company's research and development, regulatory and medical affairs.

May 13, 2013

The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

WASHINGTON — The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

Money, who has worked for the GPhA for six years, was previously the organization's senior director for federal affairs. In the new position, he will continue lobbying on behalf of the generic drug industry in Congress.

May 7, 2013

The global market for biosimilars will be worth nearly $2.5 billion this year, according to a new study.

LONDON — The global market for biosimilars will be worth nearly $2.5 billion this year, according to a new study.

The study, by British market research firm Visiongain, forecast that the $2.445 billion market size marked more than 20% of growth from 2012 and would account for about 2% of the overall market for biologics. The market is expected to grow rapidly through 2023 as biosimilars hit the market in the United States and European Union.