Bio Farma and MSD Launch NUSAGARD, Locally Manufactured 4-Valent HPV Vaccine in Indonesia

August 2, 2023 3:00 pm ET

The launch of NUSAGARD is the realization of the partnership between MSD and Bio Farma to improve capabilities and increase capacity of local vaccine manufacturing
The availability of NUSAGARD 4-valent HPV vaccine will enable a sustainable national immunization program for HPV

Jakarta, Agustus 2^nd 2023 – Bio Farma Holding SOE Pharmaceuticals, with subsidiaries Kimia Farma and Indofarma, partnering with MSD (trade name Merck &; Co., Inc., Rahway, N.J., USA), launched NUSAGARD, a locally manufactured 4-valent human papillomavirus (HPV) vaccine in Indonesia. The launch of NUSAGARD in Jakarta, Indonesia was attended by Penny K. Lukito, Head of Drug and Food Monitoring Agency (BPOM); Dante Saksono Harbuwono, Deputy Health Minister; Aditya Dhanwantara, Assistant Deputy of Health Industry from Ministry of State-Owned Enterprise; George Stylianou, Managing Director of MSD Indonesia; Shadiq Akasya, Director of Bio Farma Induk Holding; Representative of the US Embassy in Indonesia, and MSD Asia Pacific Representative.

The launch of the NUSAGARD vaccine is a realization of the partnership agreement signed between MSD and Bio Farma on 13^th December 2022, in Jakarta. With the presence of this locally manufactured HPV 4-valent vaccine, it is expected to improve access and expand coverage of HPV vaccination in Indonesia.

The Indonesian Government continues to encourage broad access to HPV vaccination in Indonesia through expanded HPV immunization coverage via a National Immunization Program (NIP). The school-based HPV NIP is scheduled to commence in August 2023 through the School Based Immunization Month (BIAS) Program.

Head of Agency for Drug and Food Control (BPOM), Penny K. Lukito, stated that the availability and access to a safe and high-quality HPV vaccines is very important. Therefore, BPOM is committed to continuing in assisting the NUSAGARD vaccine production process with the hope that gradually Bio Farma can do the end-to-end local production of NUSAGARD vaccine in the future, including the manufacture of active substances (drug substance), fill-and-finish process, to finished products.

”In line with the Presidential Instruction No. 6/2016 on Acceleration of the Development of Pharmaceutical and Medical Device Industry, we need to have the ability to produce HPV vaccine to meet the needs of HPV immunization program. We appreciate Bio Farma for this technology transfer partnership with a global vaccine company – Merck Sharp & Dohme (MSD). The partnership between national and global pharmaceutical companies to develop NUSAGARD 4-valent HPV vaccine hopefully can inspire other collaborations, so that many more vaccines could be produce locally, hence accelerating the realization of Indonesia’s goal of vaccine self-sufficiency,” said the Head of Agency for Drug and Food Control (BPOM).

“This partnership between Bio Farma and MSD is a step that we hope will allow us to actively contribute towards health resilience in Indonesia. This is just the beginning of more contributions that will improve our healthcare industry. Once again congratulations, hopefully this collaboration can continue and become a start of the awakening of our health industry.” said the Assistant Deputy of Health Industry from Ministry of State-Owned Enterprise.

“The Ministry of Health continues to make significant progress in the transformation of our healthcare system, including through the transformation of the health resilience system and pharmaceutical sector in Indonesia. The launch of the locally-manufactured NUSAGARD 4-valent HPV vaccine is a unique example of technology transfer from the global pharmaceutical company MSD to the state-owned company, Bio Farma. This is a major milestone for Indonesia, particularly for the health sector, and we appreciate this strategic partnership and collaboration to support our continued healthcare transformation in Indonesia.” added the Deputy Minister of Health, Dante Saksono Harbuwono.

Director of Bio Farma, Shadiq Akasya, commented, “The launch of NUSAGARD, a 4-valent HPV vaccine, is an advance step of prevention for a cervical cancer free-generation. Bio Farma is providing accessibility, ensuring easy and affordable access from screening to vaccination. Bio Farma’s partnership with MSD is increasing the opportunity and momentous step for Bio Farma to deepen our experience, knowledge, and expertise of innovative technologies from global vaccine manufacturer. Moreover, this partnership also encourages us to continue to innovate in providing high quality locally-produced vaccines.”

“I am incredibly proud to see the launch of NUSAGARD here in Indonesia. This is the culmination of a partnership between MSD and Bio Farma that was established back in 2016. The successful transfer of MSD’s 4-valent HPV vaccine technology to Bio Farma has produced Indonesia’s first locally manufactured HPV vaccine. We look forward to seeing NUSAGARD being incorporated into the nationwide HPV immunization program this August. At MSD we are committed to reducing the incidence of cervical cancer here in Indonesia and fully supportive of the World Health Organization’s (WHO) global strategy to accelerate the elimination of cervical cancer globally.” said George Stylianou, Managing Director of MSD Indonesia.

Peluncuran NUSAGARD merupakan wujud nyata kerja sama antara Bio Farma dan MSD untuk meningkatkan keahlian dan kapasitas produksi vaksin dalam negeri
Keberlangsungan ketersediaan NUSAGARD vaksin 4-valent HPV diharapkan menjadi salah satu bentuk dukungan terhadap program imunisasi HPV skala nasional yang berkelanjutan

Jakarta, 2 Agustus 2023 – Bio Farma Induk Holding BUMN Farmasi, dengan anak perusahaan Kimia Farma dan Indofarma, bekerja sama dengan MSD (nama dagang Merck & Co., Inc., Rahway, N.J., USA) meluncurkan NUSAGARD, vaksin human papillomavirus (HPV) 4-valen MSD yang diproduksi di dalam negeri. Peluncuran vaksin NUSAGARD dilaksanakan di Jakarta turut dihadiri oleh Penny K. Lukito, Kepala Badan POM; Dante Saksono Harbuwono, Wakil Menteri Kesehatan; Aditya Dhanwantara, Asisten Deputi Industri Kesehatan Kementerian BUMN; Shadiq Akasya, Direktur Utama Bio Farma; George Stylianou, Managing Director MSD Indonesia; Perwakilan Kedutaan Besar Amerika Serikat di Indonesia, serta Perwakilan MSD Asia Pasifik.

Peluncuran vaksin NUSAGARD hari ini merupakan tindak lanjut dari penandatanganan kesepakatan kerja sama yang dilakukan oleh MSD dan Bio Farma pada tanggal 13 Desember 2022 di Jakarta. Dengan hadirnya vaksin HPV 4-valen produksi dalam negeri, diharapkan dapat meningkatkan dan memperluas cakupan vaksin HPV di Indonesia.

Pemerintah Indonesia terus mendorong peningkatan akses terhadap vaksin HPV di Indonesia dengan memperluas cakupan imunisasi HPV melalui Program Imunisasi Nasional. Program Imunisasi Nasional berbasis sekolah akan dilaksanakan mulai bulan Agustus 2023 melalui Program Bulan Imunisasi Anak Sekolah (BIAS).

Kepala Badan Pengawas Obat dan Makanan (BPOM), Penny K. Lukito, mengatakan bahwa ketersediaan serta akses terhadap vaksin HPV yang aman dan bermutu sangat penting. Untuk itu, BPOM berkomitmen untuk terus mendampingi proses produksi vaksin NUSAGARD, sehingga secara bertahap vaksin NUSAGARD dapat diproduksi lokal dari hulu ke hilir oleh Bio Farma, yaitu sejak pembuatan zat aktif (drug substance), proses fill-and-finish, hingga produk jadi.

”Sesuai dengan Instruksi Presiden No. 6 tahun 2016 tentang Percepatan Pengembangan Industri Farmasi dan Alat Kesehatan, kita harus memiliki kemampuan memproduksi vaksin HPV untuk dapat memenuhi kebutuhan imunisasi HPV di Indonesia. Kami mengapresiasi Bio Farma atas upaya kerja sama transfer teknologi dari produsen vaksin HPV global – Merck Sharp & Dohme (MSD). Kemitraan antara industri farmasi nasional dan global untuk menghadirkan vaksin HPV NUSAGARD diharapkan menginspirasi munculnya kolaborasi-kolaborasi lain agar lebih banyak lagi jenis vaksin dapat yang diproduksi di dalam negeri dan mendukung cita-cita Indonesia dalam mendorong kemandirian,” ujar Kepala BPOM.

“Kerja sama Bio Farma dengan MSD ini merupakan langkah yang kami harapkan untuk kita bisa berperan lebih aktif dalam menuju ketahanan kesehatan di Indonesia. Ini adalah awal dari bertambahnya kontribusi yang akan meningkatkan industri kesehatan kita. Sekali lagi kami ucapkan selamat, semoga kerja sama ini bisa berlanjut dan menjadi awal dari kebangkitan industri kesehatan kita.” ungkap Asisten Deputi Industri Kesehatan Kementerian BUMN, Aditya Dhanwantara.

“Kementerian Kesehatan terus melakukan transformasi melalui kebijakan dari hulu sampai ke hilir, salah satunya adalah transformasi sistem ketahanan kesehatan di Indonesia untuk meningkatkan ketahanan sektor farmasi di Indonesia. Peluncuran NUSAGARDvaksin HPV 4-valen produksi dalam negeri ini merupakan bentuk realisasi nyata transfer teknologi dari perusahaan farmasi global MSD yang dilakukan bersama dengan perusahaan BUMN Bio Farma. Hal ini menjadi milestone penting bagi Indonesia, terutama sektor kesehatan, dan kami sangat mengapresiasi kerja sama strategis ini yang berkolaborasi untuk mendukung transformasi kesehatan di Indonesia.” ungkap Wakil Menteri Kesehatan, Dante Saksono Harbuwono.

Direktur Utama Bio Farma, Shadiq Akasya, menambahkan, “Peluncuran NUSAGARD, vaksin HPV 4-valen merupakan langkah terdepan dalam pencegahan menuju generasi bebas kanker serviks. Bio Farma hadir untuk memberikan aksesibilitas, memastikan akses yang mudah dan terjangkau terhadap layanan terkait kanker serviks, dari mulai deteksi hingga vaksinasi. Kerja sama Bio Farma dengan MSD ini menambah kesempatan dan langkah penting bagi Bio Farma untuk memperdalam pengalaman, pengetahuan dan keahlian teknologi inovatif dari manufaktur vaksin global. Tidak hanya itu, langkah awal dari kerja sama kami ini juga memberikan semangat untuk terus berinovasi dalam menghadirkan produk-produk vaksin dalam negeri yang berkualitas.”

“Saya sangat bangga atas peluncuran NUSAGARD di Indonesia. Ini merupakan puncak dari kerja sama antara MSD dan Bio Farma yang telah terjalin sejak tahun 2016. Keberhasilan transfer teknologi vaksin HPV 4-valen MSD ke Bio Farma telah menghasikan vaksin HPV produksi lokal pertama di Indonesia. Kami berharap dapat menyaksikan NUSAGARD menjadi bagian dari program imunisasi HPV nasional pada bulan Agustus ini. Di MSD, kami terus berkomitmen untuk mengurangi jumlah kanker serviks di Indonesia dan mendukung strategi global Organisasi Kesehatan Dunia (WHO) untuk mempercepat eleminasi kanker serviks secara global” ungkap Managing Director MSD Indonesia, George Stylianou.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

About Bio Farma

PT Bio Farma (Persero) is the largest pharmaceutical state-owned holding in Indonesia engaged in health with end-to-end services, ranging from pharmaceutical research and development, manufacturing, and distribution, to the operation of retail pharmacies, clinics, and clinical laboratories. To support its business activities, Bio Farma has a head office and factory covering an area of 91,058 square meters in Bandung. The company also has a representative office in Jakarta. With a production capacity of more than 3.2 billion vaccine doses per year. Bio Farma has received certification from the World Health Organization (WHO) and has exported its products to more than 150 countries. Bio Farma is the parent company of three pharmaceutical issuers on the Indonesia Stock Exchange (IDX), namely PT Kimia Farma Tbk (KAEF), PT Indofarma Tbk (INAF). For more information, visit: www.biofarma.co.id.