분자유전학실험실 (단국대학교 분자생물학과)

 이성욱 ( 2015-03-11 14:20:55 , Hit : 995
 First U.S. biosimilar is not considered interchangeable

FDA Approves First Biosimilar Ushering in a New Era of Treatments

12:08 pm ET
Mar 6, 2015
Ed Silverman
After years of anticipation, the FDA has approved a so-called biosimilar medicine, ushering in a new era of treatments in the U.S. that are

—Getty Images/Fotosearch RF
forecast to eventually save the nation’s health care system billions of dollars and generate a new round of competition in the pharmaceutical industry. Biosimilars are cheaper copies of brand-name biologics that have demonstrated similar safety and effectiveness.

The biosimilar approved by the FDA is a version of Neupogen, a $5.7 billion drug sold by Amgen AMGN -0.92% that is used to thwart infections during chemotherapy. The copycat version will be sold by the Sandoz unit of Novartis NVS -1.83% and marketed as Zarxio. However, the Sandoz drug is not considered interchangeable, which means it cannot automatically be substituted at pharmacies.

The landmark approval comes five years after the Biologics Price Competition and Innovation Act became law as part of the Affordable Care Act and provided a pathway for the FDA to review applications from drug makers to sell biosimilars. These medicines, however, have been available in Europe and many other countries for several years.

“Biosimilars will provide access to important therapies for patients who need them,” FDA Commissioner Margaret Hamburg says in a statement announcing the approval. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

The move was quickly praised by one big payer. Express Scripts, the largest pharmacy benefits manager in the U.S., forecasts the Sandoz drug will save the health care system $5.7 billion over the next decade, assuming a 30% discount off the current price for Neupogen, which sells for about $3,500 for a 30-day supply. A Novartis spokeswoman did not respond to a question about pricing.

A point worth noting is the labeling for the Sandoz drug is fairly similar to the label for the brand-name biologic, according to Sanford Bernstein analyst Ronny Gal. There had been questions whether the label would emphasize Neupogen trial data or proof of similarity. This “suggests more rapid penetration of biosimilars and market development [that is] more along generic lines,” he writes in an investor note.

Still, some questions remain. The FDA has not yet offered guidance for determining interchangeability, which may dampen sales. Meanwhile, 25% of payers are reluctant to recommend switching an existing patient to a biosimilar and nearly one-third of physicians say they are unlikely to switch existing patients, according to the Tufts Center for the Study of Drug Development, which is partially funded by industry.

Nonetheless, the approval was greeted enthusiastically by Novartis, whose Sandoz unit is one of the world’s largest purveyors of generic drugs and already markets biosimilars in other countries. Amgen, however, did not have much to say about the approval itself, but this likely reflects ongoing litigation with Sandoz over its bid to sell a biosimilar version of Neupogen in the U.S.

The drug makers have been battling in court over the extent to which one company must provide another with detailed information about its plans for pursuing a biosimilar. The row has been closely watched for how brand-name and generic drug makers are required to resolve clashes over patent rights whenever biosimilar applications filed with the FDA. A hearing is set for next week. [UPDATE: Sandoz will not launch its drug until a federal court issues a decision regarding an Amgen request for a preliminary injunction, or until April 10, whichever is earlier- see this].

Amgen did appear pleased about one point. The FDA decided, for now, the Sandoz biosimilar will have a different International Non-Proprietary Name, or INN, than the brand-name Amgen biologic. In the medical community, health care providers often refer to the INN, or chemical name for a medicine, rather than the commercially known name, when discussing treatments.

Biosimilar naming is a controversial topic. At issue is the extent to which a different INN for a biosimilar would hamper substitution or compromise patient safety. Brand-name drug makers want biosimilars to have unique names and argue this would make it easier to track adverse events in patient records and side effect reports filed with regulators.

Generic drug makers say different names may confuse physicians and pharmacists, who may have difficulty sorting out whether medicines are really the same as they try to verify dosing and regimens. As they see it, brand-name drug makers are trying to thwart substitution.

The FDA has not set a formal policy, but noted that since the INN for Neupogen is filgrastim, the FDA says the Sandoz version for now should be called filgrastim-sndz. The generic industry trade group called this decision disruptive, while Amgen called it “an important first step” in creating “transparency and accountability.”

867   중국의 인간배아 유전자편집 연구를 바라보는 상반된 시각  이성욱 2015/04/28 1370
866   유전자 조작인간배아를 만들어낸 중국과학자들  이성욱 2015/04/27 1038
865   항체를 이용한 HIV치료법  이성욱 2015/04/15 980
864   CRISPR의 능력을 배가(倍加)시키는 미니 유전자  이성욱 2015/04/02 1151
863   여러 질환에 대한 치료제의 가능성을 보여준 신물질  이성욱 2015/03/31 997
862   안젤리나 졸리 이번엔 난소 절제, `졸리 효과` 부활하나?  이성욱 2015/03/31 999
861   Gilead secures approval in Japan for Sovaldi to treat genotype 2 chronic HCV  이성욱 2015/03/31 974
860   수지상 세포의 항암 작용을 향상시키는 갑상선 호르몬  이성욱 2015/03/30 1213
859   화학적 태그로 미래의 마이크로 RNA 표시  이성욱 2015/03/30 1483
858   생명탄생의 수수께끼를 해결한 화학자들  이성욱 2015/03/18 969
857   흔한 헤르페스 약물, 헤르페스 감염과는 별도로 HIV-1 수준 낮춘다.  이성욱 2015/03/17 1582
856   인간배아 DNA편집을 둘러싼 논란  이성욱 2015/03/17 1023
855   상처 치유 관련 미스터리 이해  이성욱 2015/03/17 945
  First U.S. biosimilar is not considered interchangeable  이성욱 2015/03/11 995
853   Drug flushes out hidden AIDS virus  이성욱 2015/03/07 1052
852   숙주 세포와는 별도로 그 활성을 조절하는 HIV  이성욱 2015/03/03 1184
851   세균이 위협을 기억하는데 도움을 주는 바이러스 절단 효소  이성욱 2015/02/25 1255
850   iPS세포 '미니 간' 대량생산장치 개발  이성욱 2015/02/23 1041
849   Paying for gene therapy: are annuities the next big thing?  이성욱 2015/02/22 1020
848   부모의 특징을 자식에게 전달하는 방식: 박테리아의 DNA  이성욱 2015/02/19 1108

[이전 10개] [1].. 21 [22][23][24][25][26][27][28][29][30]..[64] [다음 10개]

Copyright 1999-2021 Zeroboard / skin by ROBIN