Biosimilars should take same generic names as branded counterparts, Hospira’s Ramachandra says
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.
In remarks in Geneva on Tuesday at the World Health Organization’s 57th Consultation on International Nonproprietary Names for Pharmaceutical Substances, Hospira SVP and chief scientific officer Sumant Ramachandra said that European regulators had approved biosimilars with the same generic names as their reference biologics for more than six years in a system that had proved effective. Ramachandra’s remarks were from a paper that the drug maker issued last week.
The question of whether biosimilars should carry the same generic names as their reference products or carry special names has emerged as a key issue as the Food and Drug Administration works to create an abbreviated approval pathway for biosimilars, as mandated by provisions of the Patient Protection and Affordable Care Act. Biotech companies, which stand to lose billions in sales when cheaper biosimilar versions of their products enter the market — according to IMS Health, biosimilars in Europe have helped lower costs by 20% to 30%, and the Generic Pharmaceutical Association estimates they could safe the U.S. healthcare system $20 billion per year — maintain that because biosimilars will be made using separate cell lines, there is a risk that they will be different in terms of efficacy and safety.
Ramachandra also said that biosimilars have been successfully tracked in the marketplace using their brand names, meaning that a separate name isn’t necessary for keeping track of them, and that the Affordable Care Act didn’t include language requiring separate generic names. Furthermore, separate generic names could create confusion among the clinicians who rely on international and local standards to fill prescriptions, potentially resulting in safety and medication access issues.
“Biosimilars represent an enormous opportunity to put many of today’s most life-changing medicines in reach for millions more patients,” GPhA president and CEO Ralph Neas said. “It is critical that any decision on naming these products does not jeopardize that potential. That is why we are so pleased that WHO is taking a thoughtful and deliberate approach to reviewing this issue.”
Amgen acquires rights to Neupogen, Neulasta in 100 markets from Roche
THOUSAND OAKS, Calif. — Biotech drug maker Amgen has acquired from Roche the rights to drugs used to boost the immune systems of cancer patients on chemotherapy in 100 markets.
Amgen announced Tuesday that the transfer of rights to Neupogen (filgrastim) and Neulasta (pegfilgrastim) in several countries in Asia, Eastern Europe, Latin America, the Middle East and Africa would take effect on Jan. 1, 2014. Financial terms were not disclosed, but the drugs generated about $200 million in sales in those areas last year. Roche has since 1989 held the rights to the drugs in those markets under license from Kirin-Amgen, a joint venture between Amgen and Japan-based Kirin Holdings Co.
"This agreement will enable Amgen to reach more patients around the world with two of our innovative medicines," Amgen chairman and CEO Robert Bradway said. "The transaction will allow us to build experience and capacity in countries that will be important in accelerating future growth of Amgen’s pipeline products."
Study finds 1-in-50 at risk of severe allergic reactions
WASHINGTON — Nearly 1-in-50 people in the United States are at risk of severe allergic reactions, according to a new study announced Monday by the Asthma and Allergy Foundation of America.
According to the study, severe, life-threatening allergic reactions known as anaphylaxis are common in the United States, occurring in about 1.6% of the population. The rate, the study said, is probably higher, and closer to 5.1%. The study was published in the Journal of Allergy and Clinical Immunology.
"One of the most alarming things we found is that, despite the common occurrence of anaphylaxis, most people are not prepared to do the right thing when emergency reactions occur," AAFA SVP Mike Tringale said. "We need to redouble our efforts to make sure that people are informed and have access to the right medication."
Anaphylaxis can occur suddenly and typically involves two or more organs, such as the skin, airways, lungs, stomach, heart or blood vessels, and is most commonly triggered by allergies to foods, medications, latex and insect or spider bites and stings. Symptoms can include difficulty breathing, rashes, hives, swelling, vomiting, loss of blood pressure and loss of consciousness. In the public survey portion of the study, 73% of respondents reported respiratory symptoms with anaphylaxis, followed by 61% reporting skin reactions, 24% reporting cardiovascular reactions, 15% reporting neurological reactions and 7% reporting gastrointestinal reactions.
Though anaphylaxis can occur anywhere, with most occurring at home, the study indicated that most won’t have emergency medication when needed, even in their homes.
"Everyone plays an important role in recognizing and responding to anaphylaxis," AAFA chairwoman Lynn Hanessian said. "Knowing the signs and symptoms and when and how to take action, such as helping someone get emergency treatment with an epinephrine auto-injector and calling 911, is critical to helping someone having an anaphylactic reaction."