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Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching
Abstract
Biosimilars are becoming increasingly available internationally as patents expire on the originator biologic drugs they are intended to copy. Although substitution policies seen with generic drugs are being considered as a means to reduce expenditures on biologics, some biosimilars pose particular challenges in that the act of substitution may eventually lead to increased rates of therapeutic failure. As evidence requirements from regulators do not directly address this challenge, switch trials of biosimilars have emerged that may provide further answers. Using infliximab in inflammatory bowel disease as an example, we critically examine emerging evidence from two key switch trials (NOR-SWITCH and NCT) and discuss the clinical and economic implications of these and what policy options may be most reasonable for payers. Options include reimbursing biosimilars for only newly diagnosed patients, using product-listing agreements to manage uncertainty, or using tiered co-payments or other incentives to promote biosimilar use.
Key Points for Decision Makers
| The unique characteristics of some biosimilars require payers and formulary managers to revisit traditional approaches to pricing and reimbursement applied to generic drugs. |
| Evidence requirements demanded by regulators, in some cases, may be insufficient for payers to implement policies of automatic substitution. |
| Evidence emerging from switch trials of infliximab in inflammatory bowel disease may appear to provide additional needed evidence for payers, but will likely have little impact on policy decisions until evidence of interchangeability becomes available. |
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Introduction
Biosimilars are becoming increasingly available internationally as patents expire on the originator biologic drugs they are intended to copy [1]. Analogous to generic versions of small molec
K. T. S. Padannayil
Indian theatre artist and film actor (–)
K. T. S. Padannayil | |
|---|---|
| Born | Kochuparambil Thai Subramanian Padannayil () Thrippunithura, Kochi, British Raj |
| Died | 22 July () (aged 88) Thrippunithura, Kochi, India |
| Occupation | Film actor |
| Yearsactive | – |
| Spouse | Ramani ( – ) |
| Children | 3 sons, 1 daughter |
Kochuparambil Thai Subramanian Padannayil ( – 22 July ) was an Indian theatre artist and film actor who worked predominantly in Malayalam film industry. He began his acting career at the age of 21 as a theatre artist and made his film debut in through Rajasenan's comedy film Aniyan Bava Chetan Bava. Padannayil acted in more than 60 movies in various supporting and comic roles. Known for his impeccable comic timing, he is mostly remembered for his comic roles in movies such as Sreekrishnapurathe Nakshatrathilakkam, Vrudhanmare Sookshikkuka and Vaamanapuram Bus Route. He also acted in several television comedy serials.
Biography
Padannayil was born as the youngest of six children to Kochupadannayil Thai and Maani at Thekkumbhagam, Thrippunithura, Kochi in He had three brothers, Murukan, Raghavan and Shivan and two sisters, Lalitha and Lathika. He studied at Saraswathi Vilasam School, Tripunithura. He discontinued studies after sixth class due to financial difficulties. He was a theatre artist before becoming a cinema artist. He first acted in and directed amateur drama Vivaha Dallal, at Trippunithura Khadibhavan's Amber charkha spinning mill's annual day celebration. He also trained youngsters of the Children's Society at Kannankulangara. He acted on thousands of stages within 40 years. He performed at different drama troupes like Jayabharath Nithakalalaya, Chenagassery Geetha, Vaikom Malavika, Kollam Tuna and Attingal Padmasree. In a career spanning around 25 years he acted in more than 60 films and starred in more than one hundred television Rajasenan Rajasenan Rajasenan is an Indian film director, screenwriter, actor, music director, businessman, stage performer, and politician who has worked in Malayalam cinema. He is one of the most successful director in 90s malayalam film industry. Most of his films in 90s were huge successes and ran over more than days. Rajasenan also worked in the TV serial industry. He directed some serials and also acted in many other Serials too. He is mostly remembered for his association with actor Jayaram and the popular duo has worked together in 16 movies. He made his debut with the film Aagraham. His notable films include Kadinjool Kalyanam (), Ayalathe Adheham (), Meleparambil Aanveedu (), CID Unnikrishnan B.A., (), Vardhakya Puranam (), Aadyathe Kanmani (), Aniyan Bava Chetan Bava (), Kadhanayakan (), The Car (), Sreekrishnapurathe Nakshathrathilakkam (), and Darling Darling (). Rajasenan also acted in the lead role in Bharya Onnu Makkal Moonnu (), which was also directed by himself. Rajasenan had Jayaram as his lead role in 16 of his 37 films (to date), of which the vast majority were hit movies. In Rajasenan entered into politics through Bharatiya Janata Party (BJP). He contested from the Aruvikkara constituency in the Thiruvananthapuram district at the Kerala State Legislative Assembly elections, and failed to win. He is now serving as the Kerala State Council member of BJP. Rajasenan currently also entered the textile business. He and his wife currently own a grand textile shop in Thiruvananthapuram. Rajasenan also currently serves as the President of the first and only official All Kerala
Rajasenan
Born 20 August Nationality Indian Occupation Yearsactive –present Political party Bharatiya Janata Party Career